Sai Life Sciences Ltd Hiring for Senior Executive/ Assistant Manager QA(QMS) for API Manufacturing Facility /Executive – QA (MedChem)

Department: Senior Executive/ Assistant Manager QA(QMS) for API Manufacturing Facility 

• Initiation, review and approval of all types of quality management systems (Ex: Change controls, Deviations, Investigations, CAPA, OOS, and Complaints etc.
• Handling of Return Goods.
• Handling of quality system and perform risk assessment to the required quality system.
• Conduct regular internal audits as per the need basis.
• Reviewing and approving of all documents (SOP’s, Spec & STPs, Forms, protocols and reports etc.)
• Review of annual product quality review reports.
• Providing training on all cGMP topics to employees at site.
• Supporting to customer audits/ visits and regulatory audits.
• Support to provide necessary documents for amendments, annual updates and regulatory filings and CMC supporting documentation.
• Filling of questionnaires, declarations & quality agreements.
• Execution of additional responsibilities assigned by HOD

Executive – Quality Assurance (MedChem)

Key Responsibilities:

• Issue, review the R&D LNBs and ELN
• Check the compliance of observations found during review.
• Archiving of LNBs.
• Scanning of LNBs.
• Dispatch of LNBs & data as per client request.
• Conduct Lab audits and re-inspection as and when required.
• Training to new joiners for LNB writing, data integrity, good documentation practices as and when required

Key Competencies (Technical, Functional & Behavioural)

• Excellent verbal and written communication
• Persuasiveness
• Inter-personal skills
• Adaptability
• Foresight
• Understanding of business processes.

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