Executive - Production QMS

2 days ago

Bavla, India Biotech Vision Care Full time

Role & responsibilities

Execute daily production operations and ensure the efficient functioning of the department.

  • Supervise and monitor manufacturing processes to ensure compliance with quality standards.
  • Review and maintain production-related QMS elements, including Change Control, Deviation, Event Investigation, and Corrective and Preventive Actions (CAPA).
  • Prepare and review Standard Operating Procedures (SOPs), Batch Manufacturing Records (BMRs), and Batch Packing Records (BPRs).
  • Address and resolve production issues promptly to minimize downtime and ensure continuous production.
  • Respond to challenges or bottlenecks and implement mitigation strategies within defined timelines.
  • Ensure that all processes and documentation comply with SOPs and protocols.
  • Maintain and review all production-related records, including batch records, equipment logs, and production output reports.
  • Prepare regular reports on production output, efficiency, and quality metrics for management review.
  • Coordinate with the maintenance department to resolve equipment breakdowns and ensure smooth production activities.
  • Oversee the document control system to ensure the availability and integrity of quality documents.

Preferred candidate profile

  • Bachelor's or Masters degree in Pharmacy, Life Sciences, Biotechnology, or a related field.
  • Minimum of 1 year of experience in a production/QMS-related role within the pharmaceutical, biotechnology, or manufacturing industry.
  • Strong understanding of QMS principles, regulatory compliance, and production processes.
  • Ability to analyze and resolve production-related challenges effectively.
  • Proficiency in documentation, report preparation, and adherence to SOPs.

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