Senior Manager

Job Description

Position: QA Manager

Department: Quality Assurance

Years of Experience: 15+ Years

Education: M.Sc. Chemistry

Job Role: Managing Quality Assurance functions in Block B/Production

Responsibilities:

Ensure that batch production records are executed and reviewed in accordance with established SOPs and cGMP regulations. To release / reject the Batch after complete review of batch and related quality documentation. Conduct certification of BPR after completion of batch. Review and approve equipment qualification protocols and reports for accuracy, completeness, and traceability as well as adherence to protocol / procedures. Review and approve Annual Product review reports for the products as per the schedule. Track to completion all deviation and investigations related to product release. Conduct thorough investigations into and complaints for products manufactured at the site and ensure on-time closure of complaints. Run reports in electronic systems to ensure that all requirements related to batch release are met. Work directly with planning, QC, other QA functions, and Regulatory Affairs to ensure batches are released to meet supply chain requirements. Participate in self-audits of facility and equipment in partnership with Manufacturing and Engineering to ensure readiness for operations. Identify continuous improvement opportunities to increase compliance, process clarity, and operational efficiency. Review and approve Master Formula (Manufacturing / Packing Instruction) and SOPs. Review and approve process validation protocols and reports for accuracy, completeness, and traceability and well as adherence to protocol / procedures. Review and approve of QMS records in Trackwise system and ensure timely closure. To monitor timely initiation and completion of individual steps as per the work flow for all tackwise records. Provides appropriate training and development to support staff to meet their respective job responsibilities. Work in partnership with manufacturing, Engineering, and QC to increase knowledge and understanding of cGMP’s and improve practices and procedures.

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