Senior Executive/ Assistant Manager QA(QMS) for API Manufacturing Facility - Bidar
Sai Life Sciences
6 - 12 years
Bidar
Posted: 14/07/2025
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Job Description
Key Responsibilities:
• Review and approval of computerized systems application software audit trails as per SOP requirement.
• Preparing and review of specifications and standard testing procedures and analytical test reports.
• Control and maintenance of reserve samples.
• Preparation and review of working standards and working impurity standards documents.
• Preparation, review and approval of finished product certificate of analysis.
• Documents control, archival and retrieval.
• Preparation of CAPA reports, Handling of OOS and Deviations and preparing the investigation reports of the same.
• Preparation and review of validations protocols and Reports.
• Handling the change control system (CCS)
• Preparation and review of QA standard operation procedures, master list of SOPs.
• Review and approval of instrument, equipment qualification (DQ, IQ, OQ and PQ) documents.
• Preparation of Vendor Performance Assessment for Raw Materials and Evaluation of vendor.
• Preparing Product Quality Review for various products.
• Conduct internal audits and its follow up for compliance. Preparation, review, approval, and closure of internal audits.
• To help in drafting, reviewing of all departments SOP.
• Reviewing completed production batch record and laboratory records before releasing API for distribution
Key Competencies (Technical, Functional & Behavioral)
• Excellent verbal and written communication
• Persuasiveness
• Inter-personal skills
• Adaptability
• Foresight
• Understanding of business processes.
About Company
Sai Life Sciences is a leading contract research, development, and manufacturing organization (CRO/CDMO) serving global pharmaceutical innovators by providing services across the drug discovery and development lifecycle.
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