Opening in India Glycols as Sr. Executive./Asstt. Manager-QA & RA
India Glycols is a leading company that manufactures green technology based bulk, specialty and performance chemicals and natural gums, spirits, industrial gases, sugar and nutraceuticals.
The company was established as a single mono-ethylene glycol plant in 1983. Since then, IGL has brought together cutting-edge technology, innovation and an unflagging commitment to quality, to manufacture a wide range of products that have found global demand.
The company was established as a single mono-ethylene glycol plant in 1983. Since then, IGL has brought together cutting-edge technology, innovation and an unflagging commitment to quality, to manufacture a wide range of products that have found global demand.
Post: Sr. Executive./Asstt. Manager-QA & RA
Job Description:
* Quality Assurance functions (GMP, WHO-GMP, ICH Guidelines, ISO9001:2008 and ISO22000:2005 norms)
* Quality Control functions
* National /international regulatory audits, CAPA, Deviation ,OOS
* Handling Customer Complaint & Product Recalling
* Quality Assurance functions (GMP, WHO-GMP, ICH Guidelines, ISO9001:2008 and ISO22000:2005 norms)
* Quality Control functions
* National /international regulatory audits, CAPA, Deviation ,OOS
* Handling Customer Complaint & Product Recalling
Candidate Profile:
* Exposure in QA & Regulatory Affairs
* Document Controlling
* Trend Analysis-Preparation & Evaluation
* Internal Audit & Mgt Review
* Protocol- Prepartion & Validation
* Equipment Qualification
* GMP/QMS/FSMS training
* Evaluation of Batch Process
* Exposure in QA & Regulatory Affairs
* Document Controlling
* Trend Analysis-Preparation & Evaluation
* Internal Audit & Mgt Review
* Protocol- Prepartion & Validation
* Equipment Qualification
* GMP/QMS/FSMS training
* Evaluation of Batch Process
Additional Information:
Experience: 5-10 years
Location: Dehradun
Education: M.Pharm, M.Sc, B.Sc, B.Pharm
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Production, Maintenance, Quality
Apply at. rect.cell@indiaglycols.com
Work in Calyx Pharma as Corporate Quality assurance
CALYX is an US FDA inspected Active Pharmaceutical Ingredient manufacturerwith excellent custom synthesis capabilities. Corporate head quarter is located in the commercial hub of India – Mumbai with its manufacturing facilities on the outskirts of Mumbai.
Calyx was founded in 1979 and is a fast growing organization that has made its presence felt worldwide. Started as a three man team, Calyx is now a four hundred plus organization, consisting of dedicated professionals and R&D scientists. This team and infrastructure give Calyx the competitive edge over others in gram/ kilogram synthesis and multi-ton manufacturing.
Calyx was founded in 1979 and is a fast growing organization that has made its presence felt worldwide. Started as a three man team, Calyx is now a four hundred plus organization, consisting of dedicated professionals and R&D scientists. This team and infrastructure give Calyx the competitive edge over others in gram/ kilogram synthesis and multi-ton manufacturing.
Post: Corporate Quality assurance
Job Description:
1) IQ, OQ, PQ of analytical instruments
2) Calibration of analytical instruments
3) Daily round of ADL dept.
4) Working standards updation and Record maintenance
5) GMP Violations
6) SOP distribution etc
7) Training and Records of ADL-personnel
8) Specifications and SOPs review and preparations
9) Removal of outdated Specifications and SOPs
10) Checking and review of all ADL Reports and documents
11) Ensuring of cleaning of ADL Labs
12) Responsible for Internal and External Audits
13) Knowledge and good experience of QA functions
1) IQ, OQ, PQ of analytical instruments
2) Calibration of analytical instruments
3) Daily round of ADL dept.
4) Working standards updation and Record maintenance
5) GMP Violations
6) SOP distribution etc
7) Training and Records of ADL-personnel
8) Specifications and SOPs review and preparations
9) Removal of outdated Specifications and SOPs
10) Checking and review of all ADL Reports and documents
11) Ensuring of cleaning of ADL Labs
12) Responsible for Internal and External Audits
13) Knowledge and good experience of QA functions
Please Note down, not for freshers.
Additional Information:
Exp: 3-6 years
Location: Dombivli-Mumbai
Education: M.Sc, B.Sc
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: QA
Exp: 3-6 years
Location: Dombivli-Mumbai
Education: M.Sc, B.Sc
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: QA
If interested pls foward your updated resume alongwith CTC onsuchita_bangera@calyxindia.com or call on 9819589974
Career as Administrative Assistant in Clinical research at Piramal Life sciences
Piramal Healthcare Limited A major force in the pharmaceuticals and healthcare segment, Piramal Healthcare Limited, incorporating Healthcare Solutions & Pharma Solutions, has an unequivocal vision – to become the most admired pharmaceutical company, with leadership in market share and profits.
Post: Administrative Assistant in Clinical research
Job Description: * To serve as a general administrative and logistics support personnel to the Medical and Scientific Affairs team; including liaison with travel desk to arrange travel and stay of Key Opinion Leaders (KOLs)/ Investigators/ Consultants/ Data Safety Monitoring Board (DSMB) members.
* Co-ordinating with internal departments and managing the logistics for meetings organized by Medical Leads with external groups like KOLs/ Investigators/ Consultants/ DSMB members.
* Preparing and maintaining the minutes of meetings with Key Opinion Leaders/Investigators/Consultants/ DSMB members.
* Supporting release of documents after liaising with the QA team.
* Managing and maintaining study files and documentation as per regulatory requirements and ensuring compliance to applicable guidelines and providing support to the Medical and Scientific affairs team on audit requirements.
* Contacting external and internal individuals to collate relevant study information and assist in preparation of agreements.
* Liaising with finance to make arrangements for payments to Consultants/KOLs (whenever applicable)
* Co-ordinating with internal departments and managing the logistics for meetings organized by Medical Leads with external groups like KOLs/ Investigators/ Consultants/ DSMB members.
* Preparing and maintaining the minutes of meetings with Key Opinion Leaders/Investigators/Consultants/ DSMB members.
* Supporting release of documents after liaising with the QA team.
* Managing and maintaining study files and documentation as per regulatory requirements and ensuring compliance to applicable guidelines and providing support to the Medical and Scientific affairs team on audit requirements.
* Contacting external and internal individuals to collate relevant study information and assist in preparation of agreements.
* Liaising with finance to make arrangements for payments to Consultants/KOLs (whenever applicable)
Candidate Profile:The incumbent should have a degree in Science. A B.Pharm/Masters in Life Sciences degree would be desirable. Mumbai candidates would have an added advantage.
The incumbent must possess excellent communication skills. Interpersonal skills would be an asset. The role requires computer skills-MS Office, ERP-SAP working knowledge would be a must. The incumbent must have the ability to multi-task.
The incumbent must possess excellent communication skills. Interpersonal skills would be an asset. The role requires computer skills-MS Office, ERP-SAP working knowledge would be a must. The incumbent must have the ability to multi-task.
Additional Information:
Education : B.Pharm, M.Sc
Experience : 1-2 years
Location : Mumbai
Functional Area: CR
Compensation: Rupees 2,00,000 - 2,50,000
Email: research.recruitment@piramal.comContact:
1, Nirlon Complex, Off W. E Highway,
Goregaon East
MUMBAI,Maharashtra,India 400063
Telephone: 22-30818000
Education : B.Pharm, M.Sc
Experience : 1-2 years
Location : Mumbai
Functional Area: CR
Compensation: Rupees 2,00,000 - 2,50,000
Email: research.recruitment@piramal.comContact:
1, Nirlon Complex, Off W. E Highway,
Goregaon East
MUMBAI,Maharashtra,India 400063
Telephone: 22-30818000
TO apply(New users), CLICK HERE
Opportunity in Parexel as Clinical Research Associate II
PAREXEL has supported the Bio-Tech andPharmaceutical industries in helping the development of new drugs and treatments on a global basis. As a leading global biopharmaceutical service provider, they supply knowledge-based contract research, medical communications and consulting services across a broad range of therapeutic areas to the worldwide pharmaceutical, biotechnology and medical device industries. They have helped over 800 clients to develop and launch some of the most important drugs and devices of our time-helping people live better and healthier lives everywhere in the world. Headquartered near Boston, Massachusetts, PAREXEL operates in more than 50 countries around the world.
Post: Clinical Research Associate II
Job Description:
Assume the ability to meet the requirements of a CRA II with a high degree of proficiency and autonomy
Take responsibility for specific tasks on projects, or acts as the main CRA contact on individual projects
Train team members on selected tasks
Keep manager informed about work progress and any issues to avoid surprises. Requires some interaction / supervision by Manager or assigned mentor.
Build relationships with investigators and site staff
Participate in Investigator and other external or internal meetings as required
Arrange on-site visits and logistics (e.g. travel arrangements)
Perform on site visits in accordance with the monitoring plan
Conduct on-site study-specific training (if applicable)
Perform site facilities inspection
Monitor patient safety on-site (review for missing SAEs, AEs, ConMed) and address protocol violations
Monitor and maintain ICH-GCP compliance
Responsible for the completeness and quality of the on-site files
Respond to site issue alerted from Clinical Monitoring Associate (i.e, non-responsive site, Protocol Deviations concerns, quality issues etc., items that require face to face interaction)
Collect SRP documents during QV and other visits as needed
Establish site recruitment plan in collaboration with site during Qualification Visit; follow-up and update at Initiation Visit and Monitoring Visit
Update all relevant tracking system on an ongoing basis
Collaborate with CMA on site issues/actions
Generate visit/contact report in accordance with monitoring plan
Code and scan Central File documents where applicable
Ship relevant wet-ink signature documents to the Assistant or back to the site
Escalate any issues that require immediate action to the CRA Coordinator/GRO Lead
Attend audits / Regulatory Inspection if requested
Assume the ability to meet the requirements of a CRA II with a high degree of proficiency and autonomy
Take responsibility for specific tasks on projects, or acts as the main CRA contact on individual projects
Train team members on selected tasks
Keep manager informed about work progress and any issues to avoid surprises. Requires some interaction / supervision by Manager or assigned mentor.
Build relationships with investigators and site staff
Participate in Investigator and other external or internal meetings as required
Arrange on-site visits and logistics (e.g. travel arrangements)
Perform on site visits in accordance with the monitoring plan
Conduct on-site study-specific training (if applicable)
Perform site facilities inspection
Monitor patient safety on-site (review for missing SAEs, AEs, ConMed) and address protocol violations
Monitor and maintain ICH-GCP compliance
Responsible for the completeness and quality of the on-site files
Respond to site issue alerted from Clinical Monitoring Associate (i.e, non-responsive site, Protocol Deviations concerns, quality issues etc., items that require face to face interaction)
Collect SRP documents during QV and other visits as needed
Establish site recruitment plan in collaboration with site during Qualification Visit; follow-up and update at Initiation Visit and Monitoring Visit
Update all relevant tracking system on an ongoing basis
Collaborate with CMA on site issues/actions
Generate visit/contact report in accordance with monitoring plan
Code and scan Central File documents where applicable
Ship relevant wet-ink signature documents to the Assistant or back to the site
Escalate any issues that require immediate action to the CRA Coordinator/GRO Lead
Attend audits / Regulatory Inspection if requested
Candidate Profile:
Strong computer and internet skills including knowledge of MS-Office products such as Excel, Word
Strong regulatory knowledge including GCP
Excellent interpersonal, verbal and written communication skills
Sound problem solving skills
Ability to successfully work in a (`virtual) team environment
Sound presentation skills
Consultative skills
Client focused approach to work, ability to interact professionally within a client organization
Ability to prioritize multiple tasks and achieve project timelines
Able to take initiative and work independently.
Sense of urgency in completing assigned tasks
Able to travel a minimum of 65% on average
Holds a driving license where required
Effective time management in order to meet daily metrics or team objectives
Shows commitment to and performs consistently high quality work
Strong computer and internet skills including knowledge of MS-Office products such as Excel, Word
Strong regulatory knowledge including GCP
Excellent interpersonal, verbal and written communication skills
Sound problem solving skills
Ability to successfully work in a (`virtual) team environment
Sound presentation skills
Consultative skills
Client focused approach to work, ability to interact professionally within a client organization
Ability to prioritize multiple tasks and achieve project timelines
Able to take initiative and work independently.
Sense of urgency in completing assigned tasks
Able to travel a minimum of 65% on average
Holds a driving license where required
Effective time management in order to meet daily metrics or team objectives
Shows commitment to and performs consistently high quality work
Educated to degree level (biological science, pharmacy or other health-related discipline preferred), equivalent nursing qualification or other equivalent experience
Substantial monitoring experience in clinical research
Substantial monitoring experience in clinical research
Additional Information:
Experience: 2-5 years
Location: Bengaluru/Bangalore
Education: B.Pharm, B.Sc
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: CR
Division: CRS
Experience: 2-5 years
Location: Bengaluru/Bangalore
Education: B.Pharm, B.Sc
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: CR
Division: CRS
Summer Research Fellowships - 2011: Work in Jawaharlal Nehru Centre for Advanced Scientific Research | Fresher
Jawaharlal Nehru Centre for Advanced Scientific Research (JNCASR) is a multidisciplinary research institute situated in Jakkur, a locality north of Bangalore, India. It is relatively young yet well-known around the Globe.
Our mandate is to pursue and promote world-class research and training at the frontiers of Science and Engineering covering broad areas ranging from Materials to Genetics. It provides a vibrant academic ambience hosting more than 200 Researchers.
The Centre is funded by the Department of Science and Technology, Government of India and is a deemed university.
Our mandate is to pursue and promote world-class research and training at the frontiers of Science and Engineering covering broad areas ranging from Materials to Genetics. It provides a vibrant academic ambience hosting more than 200 Researchers.
The Centre is funded by the Department of Science and Technology, Government of India and is a deemed university.
Eligibility for applying:
Academic requirements:
* Students who have secured not less than 80% in Maths and Science subjects in their 10th and 12th or equivalent examinations and not less than first class in graduation and post graduation {if applicable).
Only students presently studying in I & II year of B.Sc, I, II & III year of B.E* / B.Tech. #/ B.V.Sc #/ B.Pharma.*, I year of M.Sc and I - IV year of Integrated M.Sc, with the above mentioned academic requirements should apply.
The students selected under this programme are placed with scientists at the Centre or elsewhere in India, for 2 months with a stipend of Rs. 6000 /- p.m and travel support as per Govt, of India norms.
Detailed Information and application form can be downloaded fromhttp://www.jncasr.ac.in/srfp.php or may be obtained by writing to the address mentioned below with a self-addressed envelope of 16x25 cms with stamp of Rs. 10/-
Academic requirements:
* Students who have secured not less than 80% in Maths and Science subjects in their 10th and 12th or equivalent examinations and not less than first class in graduation and post graduation {if applicable).
Only students presently studying in I & II year of B.Sc, I, II & III year of B.E* / B.Tech. #/ B.V.Sc #/ B.Pharma.*, I year of M.Sc and I - IV year of Integrated M.Sc, with the above mentioned academic requirements should apply.
The students selected under this programme are placed with scientists at the Centre or elsewhere in India, for 2 months with a stipend of Rs. 6000 /- p.m and travel support as per Govt, of India norms.
Detailed Information and application form can be downloaded fromhttp://www.jncasr.ac.in/srfp.php or may be obtained by writing to the address mentioned below with a self-addressed envelope of 16x25 cms with stamp of Rs. 10/-
The Assistant Coordinator,
Nehru Centre for Advanced Scientific Research
Jakkur, P.O.,
BanEligibility for applying:
Nehru Centre for Advanced Scientific Research
Jakkur, P.O.,
BanEligibility for applying:
Academic requirements:
* Students who have secured not less than 80% in Maths and Science subjects in their 10th and 12th or equivalent examinations and not less than first class in graduation and post graduation {if applicable).
Only students presently studying in I & II year of B.Sc, I, II & III year of B.E* / B.Tech. #/ B.V.Sc #/ B.Pharma.*, I year of M.Sc and I - IV year of Integrated M.Sc, with the above mentioned academic requirements should apply.
The students selected under this programme are placed with scientists at the Centre or elsewhere in India, for 2 months with a stipend of Rs. 6000 /- p.m and travel support as per Govt, of India norms.
Detailed Information and application form can be downloaded fromhttp://www.jncasr.ac.in/srfp.php or may be obtained by writing to the address mentioned below with a self-addressed envelope of 16x25 cms with stamp of Rs. 10/-
* Students who have secured not less than 80% in Maths and Science subjects in their 10th and 12th or equivalent examinations and not less than first class in graduation and post graduation {if applicable).
Only students presently studying in I & II year of B.Sc, I, II & III year of B.E* / B.Tech. #/ B.V.Sc #/ B.Pharma.*, I year of M.Sc and I - IV year of Integrated M.Sc, with the above mentioned academic requirements should apply.
The students selected under this programme are placed with scientists at the Centre or elsewhere in India, for 2 months with a stipend of Rs. 6000 /- p.m and travel support as per Govt, of India norms.
Detailed Information and application form can be downloaded fromhttp://www.jncasr.ac.in/srfp.php or may be obtained by writing to the address mentioned below with a self-addressed envelope of 16x25 cms with stamp of Rs. 10/-
The Assistant Coordinator,
Nehru Centre for Advanced Scientific Research
Jakkur, P.O.,
Bangalore 560 064.
Nehru Centre for Advanced Scientific Research
Jakkur, P.O.,
Bangalore 560 064.
Last dates for request for application form : 22nd November 2010
Last dates for downloading application form: from website: 01st December 2010
Last dates for receipt of completed application: 10th December 2010
Last dates for downloading application form: from website: 01st December 2010
Last dates for receipt of completed application: 10th December 2010
* Those not fulfilling the criteria are advised not to apply.
# Not eligible for applying to the Chemical and Materials Science areas of research
# Not eligible for applying to the Chemical and Materials Science areas of research
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