Vacancy in Quality Control/ Quality Assurance
- Symbiotec Pharmalab
- 2 - 7 years
- Pithampur
- 4 years ago
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Job Description
- Quality Control
Position- Chemist/ Officer/ Sr. Officer
Experience- 2-6 Years
Qualification-BSc/M.Sc
Job Description:
HPLC-
1.To perform and maintain calibration records of HPLC in QC lab.
2.To ensure proper and regular servicing of all the analytical instruments.
3.To ensure updation of all HPLC log books.
4.To initiate and completion of analytical record for HPLC.
5.To carry out HPLC analysis of Raw-materials, finish products, intermediates and working standards.
6.To perform and achieve departmental objectives.
7.To follow the guidelines of GLP and cGMP requirements.
8.To carry out instrumental analysis of stability samples
9.To maintain HPLC columns records.
10.To carry out chemical analysis of raw materials, finish products, intermediates and working standards.
.
Wet Lab:
- To carry out the analysis of raw materials, in- process, intermediates, packaging materials, finish products, water & working standards.
- To updation of log books of raw materials, in process, packaging materials and finish products.
- To updation of log books and preparation of test solution and volumetric solution.
- To maintain all calibration records.
- To perform sampling of water, raw materials, packaging materials, intermediates and finish products.
- Temperature monitoring of QC lab.
- To follow the guidelines of GLP and cGMP requirements.
- To perform calibration of instruments like pH meter, conductivity meter, Karl Fischer, Analytical Balance, LOD oven, vacuum oven and UV analysis.
- To carry out chemical analysis of raw materials, finish products, intermediates and working standards.
- Upkeep of samples under analysis and retain samples.
- Upkeep of laboratory working area.
- Destruction of expired samples timely.
- To ensure adequate identification and segregation of test samples to avoid mix up and cross contamination.
- Timely reporting of results of testing to facilitate the achievement of production schedules.
- Discussion of out of specification laboratory results with the manager, initiation of investigation of such results and submission of additional results.
- To check report from the analyst against standards and submission of inspected reports for review.
- To ensure that the records, which are made of the results of inspection and testing of materials, intermediates and finished products are formally assessed against specification.
- API Production:
Position- Chemist/Officer/Sr. Officer
Experience- 2-8 Years
Qualification-BSc/M.Sc/BE
Job Description:
1. Preparation of documents for production.
2. To co-ordinate with Production people and control manufacturing activities.
3. To co-ordinate with other departments like maintenance, QC, warehouse and QA etc. for smooth production.
4. To review production documents and check that are filled adequately and signed.
5. To ensure that correct raw materials are issued for respective batch.
6. To check status on materials during all stages of operation.
7. To co-ordinate in reviewing the non-conformance of the product.
8. To ensure congenial and safe work environment.
9. To monitor production activities to meet the products requirements.
10. To perform and achieve department objectives.
- Quality Assurance-
QMS
Position- Officer/ Sr. Officer/ Executive
Experience- 3-8
Qualification-BSc/M.Sc/Bpharm/ Mpharm
1. To issue correct version of BMR/BPR/PCOCR/MCVR and other documents.
2. To review filled Batch manufacturing record and analytical record.
3. To prepare the department SOP as and when required.
4. To maintain the records for FP/Intermediate batch release documents.
5. To prepare and review of the APQR.
6. To exercise document and data control whichever required.
7. To prepare and review of process validation and cleaning validation protocols and reports.
8. To prepare and review of audit compliance.
9. To participate in self inspection / internal audit program.
10. To initiate, wherever essential and to handle change control, deviations and incidents, CAPA, OOS, Market complaint.
11. To maintain the storage of master copies of all controlled documents.
12. To perform the work assigned by Manager-QA/Head-Quality.
IPQA-
- To issue correct version of BMR/BPR/PCOCR/MCVR and other documents.
- To review filled Batch manufacturing record and analytical record.
- Verification of work in progress of manufacturing plant in accordance to approved BMR/BPR and SOPs.
- To verify the equipment/shop floor cleaning and shall check the results of cleaning samples analysis during changeover of product.
- To perform dispatch related activity.
- To verify packing activities of finished product for dispatch as per OIS & SOP.
- To verify line clearance for next product.
- To verify the calibration and verification of weighing balance.
- To review filled Batch manufacturing record and analytical record.
- To prepare the department SOP as and when required.
- To exercise document and data control whichever required.
- To issue and retrieval controlled copies of logbooks and monthly formats of all department.
- To initiate, wherever essential and to handle change control, deviations and incidents, CAPA.
- To maintain the storage of master copies of all controlled documents.
- To verify dispensing activities of raw material required for production of API.
- Biotech-
Inoculum-
Position- Jr. Executive
Experience- 1-3 Years
Qualification- M.Sc. (Biochemistry OR Biotechnology OR Microbiology OR Life Sciences)
1. To follow the SOPs of Inoculum lab and maintain the training record.
2. To monitor the lab equipments and record their status.
3. To perform verification and calibration of lab instruments.
4. To prepare the batch media and fill the batch manufacturing record.
5. To prepare culture media and sterility media.
6. To perform the sterility test.
7. To perform and record isolation and propagation and maintenance of microbial culture
8. To perform the productivity test.
9. To follow the production planning.
10. To coordinate with QA department for issuance and submission of lab records and for calibration and validation of lab equipments.
11. To coordinate with QC and Micro department for analysis, microbial monitoring and GPT of media.
12. To coordinate with ware house department for issuance of batch media.
13. To coordinate with maintenance department for calibration and validation of lab equipments.
14. To follow the GMP and GDP procedures in Inoculum lab.
15. To perform and achieve departmental objectives.
Fermentation-
Position- Jr. Executive
Experience- 1-3 Years
Qualification- M.Sc. (Biotechnology / Microbiology) OR B.Tech / M.Tech. (Biotechnology)
1. Preparation of documents for production.
2. To co-ordinate with Production people and control manufacturing activities.
3. To co-ordinate with other departments like maintenance, QC, warehouse and QA etc. for smooth production.
4. To review production documents and check that are filled adequately and signed.
5. To ensure that correct raw materials are issued for respective batch.
6. To check status on materials during all stages of operation.
7. To co-ordinate in reviewing the non-conformance of the product.
8. To ensure congenial and safe work environment.
9. To monitor production activities to meet the products requirements.
To perform and achieve department objectives.
Interested candidates please share cv on ru**********p@sy******c.in
Job Classification
Industry: Pharma, Biotech, Clinical ResearchFunctional Area: Production, Manufacturing, Maintenance,
Role Category: Production/Manufacturing/Maintenance
Role: Production/Manufacturing/Maintenance
Employement Type: Full time
Education
Under Graduation: B.Tech/B.E. in Any Specialization, B.Sc in Any Specialization, B.Pharma in Any SpecializationPost Graduation: MS/M.Sc(Science) in Any Specialization, M.Tech in Bio-Chemistry/Bio-Technology
Doctorate: Any Doctorate in Any Specialization, Doctorate Not Required
Contact Details:
Company: Symbiotec PharmalabAddress: Plot No 5-8,Phase-II,Pharma Zone, Special Economic Zone ( SEZ ) , Pithampur, Distt. Dhar , DHAR, Madhya Pradesh, India
Location(s): Pithampur
Keyskills: Biotechnology UV Karl Fischer Microbiology Process Validation Upstream Chemical Analysis IR Biochemistry Lab Fermentation Change Control QC Market Complaints OOS OOT QMS Finished Products Api Production Vendor Qualification Deviation HPLC Sterility Testing Quality Control
Symbiotec Pharmalab
As the only fully, Vertically Integrated manufacturer of Steroid-Hormone APIs in India, we offer the unique proposition of providing Steroid-Hormone API Solutions with regulatory support matching 'Western Standards' with 'Asian Cost Advantage'. The company has successfully completed the construct...
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