Senior Executive- QA

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.