Company: Novartis Healthcare Ltd
Post: Executive QA
Experience: 5-10yrs
Qualification: MPharm/BPharm
Location: Mumbai
Job description
- 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 the shop floor, warehouse, and engineering along with documentation.
- Investigation of the complaint, deviation, and OOS to ensure appropriate root cause analysis and CAPA plan.
- Review all BMR, and BPR for their correctness and retention until destruction.
- Review of quality records on a periodical basis and review of analytical data in COA. Issuance of BMR, BPR, Cleaning checklists, Logbook, and Labels as per requirement.
- A 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.
- Training of new employees, system practices and procedures to develop competency.
- Review and approval of executed batch manufacturing, packaging documents other quality documents.
- Handling of material on the shop floor through approval for MRN, LRN, and MRQN.
- Submission of In-process analysis report from QC to production after review. Handling of non-conformance. Online stage-wise BMR/BPR review.
- Handling of SAP track-wise activity as per Quality Assurance procedure. Approval of line clearance during product changes over/ Batch change over.
- To ensure the Environment, Health and Safety related activities are completed.
- To report near misses and incidences as observed as per EHS requirements.
- To ensure data integrity compliances at the site and while performing activities
- M. Pharm/B. Pharm. from a reputed institute with more than 5 years of experience in a pharmaceutical company.
- Having good interpersonal skills and stakeholder management.
- 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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