Msc Chemistry Executive – Quality Assurance Post Vacancy at Sanofi
Msc Chemistry Executive – Quality Assurance Post Vacancy at Sanofi. Chemistry Candidates with master’s degree are encouraged to apply online at Sanofi for Executive – Quality Assurance officer vacancies that are available. Sanofi is hiring Chemistry candidates for Officer vacancies. Interested candidates may apply online. Check out all the details on the same below:
Job Title:
Eligibility: M.Sc. (Chemistry)
Experience: 4 to 6 years of experience in the Pharma industry with related experience in the following fields: QC, QA, Manufacturing, Regulatory affairs.
Technical skills & Competencies / Language
- Knowledge of GMP & Regulatory requirements.
- Leadership skills.
- Analytical ability.
- Planning ability.
- Communication skills.
- Problem solving.
- Team building.
KEY ACCOUNTABILITIES
Quality Management/ Continuous Improvement
Management & control of SOPs, Master documents, labels & other GMP impacted documents. Review of Batch Manufacturing Records (BMRs), Analytical record & related documentation. Deviation Investigation. Change control review & management. Batch Rework/Reprocessing Approval. Approval of repacking, relabeling & non-standard batch size procedures as per applicable SOPs.
Compliance
Ensure adherence to Corporate Quality Directives, Local FDA regulations by
- Knowing the requirements.
- Performing Gap analysis & making a compliance plan for closure of gaps.
- Supporting Regulatory Affairs in related documentation.
- Prepare for & attend to external/regulatory quality audits.
- Review calibration & preventive maintenance program.
Documentation Control
- Preparations of quality system SOPs.
- Review of other departmental SOPs.
- To ensure controlled distribution & archival of documents & records.
- Control change in master documents & records through change control procedure.
Assuring quality of products by
- Ensuring compliance with applicable SOPs.
Management of deviation/failure investigations.
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By controlling the changes made to facility/equipment/product/process & master documents & records by following change control procedure.
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By ensuring implementation of corrective & preventive actions proposed in deviation/ failure investigations, audit/ inspection compliance, customer complaint investigations.
Training
To develop cGMP training modules & impart training.
Coordination
- IQC (Pharmaceuticals-Ankleshwar): For testing of water for microbiological attributes, environmental monitoring, stability program & local regulatory compliance.
- HR&A for training activity.
- Purchase (Mumbai & Ankleshwar): For co-ordination of supplier QA activities.
- IS- Ensure IS Compliance in coordination with IS experts.
Other
- Coordinating with various agencies for making of the quality agreements.
- Implementing the pest control program at Chemistry Site.
- Implementation of the stability program & review of the same.
- Identifying & correcting unsafe conditions or behaviors & promptly reporting other potentially hazardous situations.
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