Job Description:

Job Description:
* To ensure all relevant quality related documents are prepared, approved, implemented and followed.
* Assuring that the right quality products reach 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

📌 Executive / Senior Executive / Assistant Manager - Quality Assurance (Surat)
🏢 SDP HR Solution
📍 Surat