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Assistant General Manager QA
6 months ago
Role Objective:
Develop, implement, and maintain QMS. Authorize SOPs and master documents. Ensure compliance with regulations. Manage quality projects and conduct audits. Provide GMP and QMS training. Ensure product quality and business continuity.
Desired Candidate Profile:
We are seeking a detail-oriented and highly skilled individual with Minimum of 18 years of experience in Quality Assurance within the medical device industry, with a strong understanding of regulatory requirements (e.g., FDA, ISO 13485).
Responsibilities:
- To Design, develop and implement QMS system
- To authorize the SOP of QA/QC and other master documents like Specification (RM/PM/FP/ IP), Test Procedure, BMR / BPR, Stability Protocol, All validation protocol, Internal Audit Planner, Annual Training Schedule, and Vendor Audit Schedule, Artwork.
- To Approve SMF, VMP and QM
- Approve Pre and Post Execution of Qualification and stability summary Report
- To ensure the procedure compliance for the QMS System like CCN, Deviation, Market Complaint, OOS, and CAPA and IPQA Non-conformance.
- Approve responsible and quality related customer complaint investigation and trending related activities
- Ensure manufacturing process meets with standard both national and international level
- Identification of train9ing need and provide training Regarding GMP and QMS
- Leading quality based project based working as part of multidisciplinary term as required
- Responsible as MR, to conduct and plan MRM and Prepare Report and closures
- Conduct Self inspection and audit as per schedule
- Approve destruction of retain sample after retention period
- Review and approve new document for new product launch
- To Support and maintain business continuity management plan
- To conduct training to all department personnel for the GMP, GDP, Routine Validation, In process checks activities, SOP’s as per Annual Schedule.
Biotech is an Equal Opportunity Organization promoting diversity while ensuring no discrimination on any ground including gender, race, religion, age, sexual orientation, disability, etc.
