Monday, November 29, 2010

Pharmaceutical Jobs

Universal Medicare Private Limited looking for professionals in multiple fields | Production, QA, QC

Universal Medicare Private Limited has been in the forefront of manufacturing and marketing Nutraceutical products for over two decades, and has a tie up with Geltec Private Limited, the World leader in patented Soflet® / Geltab® technology, and one of Asia's largest manufacturers of soft gelatin capsules.
Universal Medicare has state of the art manufacturing facilities at Sarigam (Gujarat) and Bangalore. Both facilities meet the International GMP standards with World class R&D centre, high-tech equipments and exceedingly qualified personnel. Geltec enjoys the status of accreditation from many renowned World Bodies like U.K. MHRA, Australian TGA and WHO.
Post: General Manager-production
Science / Pharma graduate with 8-10 years experience in a regulatory approved formulation unit and must be capable of handling Plantoperations independently. Exposure to Sof tgei manufacturing is desirable. Knowledge of current GMP practices would be pre requisite
Post: Production Chemist
Science or Pharmacy graduate with a minimum of 5 years must be approved for the manufacture of tablets. Must be thoroughly conversant with production planning; scheduling and shop floor quality control. Knowledge of marurfacture of Softgel capsules will be an advantage.
Post: Chemist - QC
Pharmacy graduates with a minimum of 3 years experience in modern  Pharma Plant. Should be familiar with modern analytical instruments and techniques.
Post: CHEMIST - QA
Science / Pharmacy graduates with minimum of 3 years shop floor experience in modern Pharma Plant with experience in validation, regulatory and documentation.
Compensation package will not be a constraint. Company also operates an attractive performance based incentive scheme. 
Interested candidates may please email Their CV before 4th dec, 2010 to: 
hrd_gj@universalmedicare.com

Walk in Job: Phthalo Colours & Chemicals (I) Ltd. require Production Chemist | 3 Posts

Phthalo Colours & Chemicals (I) Ltd. is the flagship chemical manufacturingCompany of the Nanavati Group. It was promoted in 1993 by Mr. Priyam S. Jhaveri. It started manufacturing Copper Phthalocyanine Blue Crude with a capacity of 600 MT p.a. which has been increased over a period of time to its present capacity of 7380 MT p.a.
As a part of a disciplined growth strategy, the Company forward integrated in March, 2006 into manufacturing of Phthalocyanine Pigments and Dyestuffs by way of inorganic growth. It acquired an existing Pigment and Dyestuff manufacturing Unit located in the vicinity of its Copper Phthalocyanine Blue Crude manufacturing Unit at Vapi, Gujarat.
We are well established pigment manufacturing company based at Vapi having global presence would like to invite candidates for WALK IN INTERVIEW for following posts
SENIOR CHEMIST- PRODUCTION    ....3 Posts
(WALK IN INTERVIEW DT:6th DEC 2010) Candidate should BPharm or BSC Graduate and should have experience of atleast 3 to 4 years in production. He should be well conversent with the day to day activities'of production & related areas. Knowledge of ETP plant will be an added advantage.
Fresh candidates can also appear for the above post.
PHTHALO COLOURS & CHEMICALS (I) LIMITED (UNIT-I)
Plot No.2,Phase-1,
GIDC, VAPI-396195.
(Dist.Valsad) Gujarat.
Phone : 2400033 / 2400163

Validation of QC Chemist

1.0      Purpose      :     To provide an instruction for the validation of QC Chemist.

2.0      Objective     :   To provide a documented procedure for the validation of QC Chemist.

3.0        Scope     :  This procedure is applicable for QC Chemist of ----Pharmaceuticals Ltd,.

4.0      Responsibility  :
·       Primary      :  QC Chemist / QC-Officer
·       Secondary :  Overall: QC – In charge

5.0      Procedure    :
·       Following method used for the validation of QC Chemist to confirmed his / her analytical skills.
Ø         QC In-charge identifies a previously analyzed and approved batch sample.
Ø         Identified batch sample shall be coded and hand over to QC Chemist with all the
                 details of test procedure.
·       QC Chemist qualified on the criterion as follows:
Ø            QC Chemist performs the analysis and documents the result as per Good             Laboratory  Practices.
Ø            QC Chemist performs the analysis and meets the acceptance criteria as per below
                        mentioned table.
Ø            The QC Chemist working in laboratory shall be qualified on one or more tests as
                          required by the QC In-charge.
Ø            The QC Chemist shall be qualified once a year.
Ø            A record shall be maintained.
Ø            Incase of QC Chemist fails to meet the criteria, the QC Chemist shall be trained and  re-qualified. The training record shall be recorded

                Acceptance Criteria for Chemist Validation
Sr. No.
Test
Acceptance Criteria
01
Assay test by HPLC
% RSD of Retention Time and Area of six replicate injection should not more than 2 %
02
Impurity test by HPLC
% RSD of two replicate injection for highest impurity should not more than 10 %
03
IR test
Three separate analysis, which shall be concordant with each other.
04
Water / LOD test
% RSD of triplicate analysis should not more than 2 %
10 % moisture / LOD range 0 to 0.5 % 
5 % moisture / LOD range 0.5 to 2.0 % 
2 % moisture / LOD range 2 % above
05
UV test
% RSD of three replicated absorption of solution of particular concentration at specified wavelength should not be more than 2 %
06
GC test
% RSD of Retention Time and Area of six replicate injection should not more than 2 %
07
Sp. Gravity test
% RSD of six replicates reading should not more than 2 %
08
Specific Optical Rotation test
% RSD of six replicates reading should not more than 2 %
09
Assay by chemically test
% RSD of six replicate analysis should not be more than   2 %

Cleaning of Quality Control Department

1.0         Purpose     :   To provide an instruction for cleaning of quality control department.

2.0         Objective  :     To provide a documented procedure of cleaning of quality control department.

3.0            Scope      :   This procedure is applicable for cleaning of quality control department at (Place).

4.0         Responsibility   :
·   Primary      : QC Chemist / QC-Officer
·    Secondary : Overall: QC – In charge

5.0       Procedure   :
·  Cleaning procedure.
Ø      Clean the floor with the help of a non-shredding broom.
Ø      Take a clean dry cloth & tap water in a plastic bucket & add the disinfectant and cleaning agent in the proportion prescribed.
Ø      Clean the floor by mopping with the disinfectant or cleaning agent solution as per schedule.
Ø      Clean the walls and doors by wet mopping and than dry mopping.
Ø      Clean the ceiling, tube-lights by dry mopping.
Ø      Clean the working tables after every analysis and at the end of every day by dry mopping.
Ø      Clean all the instruments with a dry cloth.
Ø      The cloth used for mopping should be cleaned with soap solution. After every use & rinsed free from disinfectant or cleaning agent & allowed to dry in air.
·        Cleaning schedule :
Ø      Floor: Twice a day
Ø      Walls and door: Weekly
Ø      Ceiling and tube lights: After 15 days
Ø      Working tables: Daily or as an when required
Ø      Instrument: Daily

Record Maintained by Quality Control

1.0      Purpose      :    To provide instructions for record maintained by quality control department.

2.0      Objective  :  To provide a documented procedure for record maintained by quality control department.

3.0         Scope       :      This procedure is applicable for record maintained by quality control department --- Pharmaceuticals Ltd., 

4.0         Responsibility  :

·       Primary        :     QC Chemist / QC Officer
·       Secondary    :      Overall : QC In Charge

5.0       Procedure   :
·       Following are control documents.
Ø            Standard Operating Procedures of Quality Control Department..
Ø            Specifications of Raw material.
Ø            Specifications of Packing material.
Ø            Specifications of In-process / intermediate.
Ø            Specifications of Finished product.
Ø            Standard Test Procedures of Raw material.
Ø            Standard Test Procedures of Packing material.
Ø            Standard Test Procedures of In-process / intermediate.

Ø            Standard Test Procedures of Finished product.
Ø            List of Instruments.
·        Following are records.
Ø            Raw materials testing records.
Ø            Packing materials testing records.
Ø            In-process / intermediates testing records.
Ø            Finished products testing records.
Ø            Instrument calibration records.
Ø            Stability study records.
Ø            Instrument calibration records.
Ø            Glassware calibration records.
Ø            Raw material inward logbook
Ø            Raw material work sheet issuance logbook.
Ø            Intermediate inward logbook.
Ø            Intermediate work sheet issuance logbook.
Ø            Finished product inward logbook.
Ø            Finished product work sheet issuance logbook.
Ø            In process samples inward logbook.
Ø            Instrument uses logbooks.
Ø            HPLC column logbook.
Ø            Stability chamber logbook.
Ø            Laboratory cleaning logbook.
Ø            Volumetric solution logbook.

Ø            Standard reagent solution logbook.
Ø            Indicator logbook.
Ø            Retention sample logbook.
Ø            Logbook issuance logbook.
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