Department DetailsRole Summary1. Constantly reviews the operation of the plant to monitor production and quality, anticipating and solving problems in timely manner, and identifying opportunities for improvement. Participates in projects that improve efficiency and/or reduce operating costs.
2. Adherence to Safety, Health and Environment measures.
3. Monitoring and control of specific production operations per standard operations procedures.
4. Adherence to and creating awareness about Standard Operating Procedures and product specifications.
5. Entering data in Quality Records & maintenance of the same.
6. Finished product quarantine/inspection/packaging/storage.
7. Creating awareness related to cGMP and plant safety.
8. Identifying product/system non-conformities and implementation of corrective/ preventive actions in specific areas of operation.
9. Preparation of BMR's SOP's, ECC's, EOP's, Checklists and Log sheets.
10. Carry out periodic review of production systems & ensure general Plant maintenance.
11. Communicates directly with QA/QC to ensure effective participation in the
implementation of QA policies and procedures.Technical / Functional Skills:
1. Good knowledge in Centrifuge, Drying, Filtration techniques, chromatography operations, bioprocess, techniques & aseptic operations.
2. Excellent knowledge required in people management, quick and effective decision-making and thorough planning, organizing and follow ups.
3. Should have experience in Current Good manufacturing practices (cGMP).
4. Good documentation skills. Awareness of audit requirements.
5. Good knowledge in MS office.Key Responsibilities1. Constantly reviews the operation of the plant to monitor production and quality, anticipating and solving problems in timely manner, and identifying opportunities for improvement. Participates in projects that improve efficiency and/or reduce operating costs.
2. Adherence to Safety, Health and Environment measures.
3. Monitoring and control of specific production operations per standard operations procedures.
4. Adherence to and creating awareness about Standard Operating Procedures and product specifications.
5. Entering data in Quality Records & maintenance of the same.
6. Finished product quarantine/inspection/packaging/storage.
7. Creating awareness related to cGMP and plant safety.
8. Identifying product/system non-conformities and implementation of corrective/ preventive actions in specific areas of operation.
9. Preparation of BMR's SOP's, ECC's, EOP's, Checklists and Log sheets.
10. Carry out periodic review of production systems & ensure general Plant maintenance.
11. Communicates directly with QA/QC to ensure effective participation in the
implementation of QA policies and procedures.Technical / Functional Skills:
1. Good knowledge in Centrifuge, Drying, Filtration techniques, chromatography operations, bioprocess, techniques & aseptic operations.
2. Excellent knowledge required in people management, quick and effective decision-making and thorough planning, organizing and follow ups.
3. Should have experience in Current Good manufacturing practices (cGMP).
4. Good documentation skills. Awareness of audit requirements.
5. Good knowledge in MS office.Educational QualificationsRequired Education Qualification: B.Tech
Required Experience: 0 - 7 years
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