Title:  Senior Manager - 2

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.