Executive Quality Assurance
Novartis
Full time- 5+ years
- Not Disclosed
- Mumbai, India
- Post Date: Jan 27, 2023
- End Date: Mar 27, 2023
- 5+ years
- Not Disclosed
- Mumbai, India
- Post Date:Jan 27, 2023
- End Date: Mar 27, 2023
Skills:
- pharma
- Quality control
- pharmacovigilance
Job Description:
Responsibilities
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Ensure and coordinate that QA activities are being done as per laid down procedure. To ensure that Production adheres to GMP standards, procedures, and systems in all respects of manufacturing including storage. Monitoring of product quality, in-process control, and manufacturing environment. Ensure effective implementation of the Quality system and procedure as per cGMP requirement at shop floor, warehouse, and engineering along with documentation. Investigation of the complaint, deviation, and OOS to ensure appropriate root cause analysis and CAPA plan.
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Review all BMR, and BPR for their correctness and retention until destruction. Review of quality records in a periodical basis and review of analytical data in COA. Issuance of BMR, BPR, Cleaning checklists, Logbook, and Labels as per requirement.
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Sampling of FG control samples, stability samples and other samples as per requirement along with related documentation. Responsible for alarm review and trending as and when required.
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Training of new employees, system practices and procedure to develop competency. Review and approval of executed batch manufacturing, packaging documents & other quality documents. Handling of material on shop floor through approval for MRN, LRN, and MRQN.
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Submission of In-process analysis report from QC to production after review. Handling of non-conformance. Online stage wise BMR/BPR review.
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Handling of SAP & track wise activity as per Quality Assurance procedure. Approval of line clearance during product changes over/ Batch change over.
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To ensure the Environment, Health and Safety related activities are completed.
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To report near miss and incidences as observed as per EHS requirement. To ensure data integrity compliances at the site and while performing activities.
Qualification & Experience
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M. Pharm/B. Pharm. from reputed institute with more than 5 years of experience in a pharmaceutical company.
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Having good interpersonal skills and stakeholder management.
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Experience in Shop floor activities, QMS, Audit & Other GMP activities, Engineering services, Quality decision making, Knowledge of production systems, IT Applications & tools, TQM and related industry GxP standards and processes.
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Salary
Not Disclosed
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Role
Others
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Area of Practice
- Pharmacology/ Pharmacovigilance
- Life Sciences
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Experience
5+ years
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