R.N. Laboratories Private Limited | Quality Assurance Manager
3 days ago
We are looking for a highly skilled and experienced person overall, as a QA Dy. Manager for an API pharmaceutical plant, your primary responsibility is to establish and maintain a robust quality management system to ensure the production of safe, effective, and compliant API products.
- To ensure all relevant quality related documents are prepared, approved, implemented and followed.
- Assuring that the right quality products reaches the customer.
- To ensure critical deviations are investigated and resolved.
- To lead the internal audits and external periodically and follow up actions for its Compliances.
- To identify gaps and implement quality systems accordingly.
- To conduct vendors audits and evaluate according to the written procedures.
- To guide on validations protocols and execution of validations i.e. Process validation, Cleaning validation, MLT, Analytical Method validation etc.
- Review and approval of Raw Materials (RM), Packaging Materials (PM), Intermediates and Finished Goods (FG) specifications.
- Review and approval of Batch records.
- Review of Site Master File, Master validation Plan for any changes.
- Conduct internal departmental meetings.
- Conduct intra departmental meeting related to quality issues.
- To perform product quality reviews in time.
- CAPA management, Applied CAPA implementation.
- To ensure appropriate stability studies are performed and evaluate the stability trend results.
- To ensure that manufacturing and testing equipment’s are appropriately calibrated.
- To ensure that effective change control is followed.
- To ensure that all processes and procedures followed are adequately validated and equipment’s are adequately qualified.
- To conduct management review meeting periodically.
- Co-ordination with Technical Director for arrangement on major resources and decision.
- Co-ordination with Department Heads and all individuals of Production, Warehouse, Engineering, Quality control, Human Resources.
- Co-ordination with Vendors and Customers.
- Co-ordination with Regulatory Authorities.
- Release or rejection of Active Pharmaceutical Ingredients (APIs).
- To help resolve all quality related complaints in a timely manner.
- To handle product recall if required
- To responsible for risk analysis activities of all departments.
- To conduct technical trainings and create awareness of current Good Manufacturing Practices (cGMP) / Regulatory requirements.
- To implement, maintain and continuously upgrade quality system in the unit to meet current requirements.
- To ensure compliance on major non-compliance highlighted by regulatory authorities and customer audits.
- To monitor destruction activity of control sample perform on time.
Authorities
- Authorized to Approve or disapprove any material viz., RM/PM/INT/FP or any incoming material subjected to quality matters, on consultation with Head QA.
- To approve/disapprove any document as required viz, change control, SOP, specification Mfg. process etc. Authorized to make necessary changes in the process without adversely affecting quality of the product. Reporting independently directly to the Head QA, on the performance of the quality management system.
- To audit incoming material supplier at any time. To provide or to conduct trainings as per the schedule and in case of any failures noticed.
- Authorized to take decisions pertaining to quality systems in absence of Head QA/QC/RA with consultation of next level to head QA/QC/RA.
Education Qualification
M. Pharma / B. Pharma with 12+ Years of experience in Quality Assurance in API Unit.
Audit Exposure
Experience of handling USFDA, EDQM, ANVISA, GMP, etc audits
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