Senior Executive- QA
3 days ago
Roles and Responsibilities
- Review and approval of Master Documents such as Batch manufacturing record /Batch packaging record, Specification, Standard test procedure, Standard operating procedure, Qualification/ Validation protocols and reports.
- Preparation and review of Site Master File.
- Review and approval of Quality System document such as Deviation, Change Control, OOS, OOT and Annual product review.
- Handling of Market Complaints, FAR, Recall and Market withdrawal of Drug Products.
- Responsible for Vendor Qualification, Batch release & SAP related activity.
- To conduct self-audits and participation, review and implementation of regulatory and other audit compliance observation.
- To perform CGMP quality audits and compliance of Cross Functional Department, External Manufacturing Sites, Suppliers/Vendors, Contract Testing laboratories and service providers as applicable.
- To conduct management review meetings, site quality council meetings etc. and compilation of data, presentations and minutes of meetings.
- Management of Control sample room for retention samples.
- Ensure retention of documents and records as per regulatory requirements.
- Review and approval of executed BMR/ BPR.
- In-process Quality Assurance during production activity and sampling at different stages of Processing /Packing as per the requirement.
- Review and approval of Hold time study protocols and summary report.
- Review and approval of stability grid.
- Review and implementation of CQA SOP at site.
- Preparation and review of quality assurance SOP.
Desired Candidate Profile
- Graduate degree in Pharmacy.
- Excellent interpersonal & communication skills.
- Must have worked in USFDA approved facility.
- Must have worked in MDI, DPI, Derma & Nasal formulation.
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