Executive QMS Production

4 weeks ago

Ahmedabad, Gujarat, India Biotech Healthcare Full time

Role Objective:

The key objective of this position is to oversee daily production operations while ensuring adherence to quality management system (QMS) standards. This role involves supervising manufacturing processes, maintaining production-related documentation, and addressing challenges to minimize downtime and improve efficiency. The individual will collaborate with cross-functional teams to ensure seamless operations and compliance with industry regulations.

Desired Candidate Profile:

  • Bachelor's or Master's degree in pharmacy, life sciences, biotechnology, or a related field.
  • Minimum of 3 to 5 years 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.

Role and 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.

Functional Skills Required:

  • In-depth knowledge of QMS principles and manufacturing processes.
  • Strong analytical and problem-solving skills.
  • Proficiency in documentation and report preparation.
  • Ability to interpret and implement regulatory guidelines.
  • Hands-on experience with production monitoring tools and techniques.

Behavioral Skills Required

  • Strong leadership and team management abilities.
  • Effective communication and interpersonal skills.
  • Ability to work under pressure and meet deadlines.
  • Detail-oriented with a focus on continuous improvement.
  • Adaptability and willingness to take initiative.

Team size to be handle:

  • This is an individual contributor role, reporting directly to the AGM, Production.

Learn more at:

Biotech is an Equal Opportunity Organisation promoting diversity while ensuring no discrimination on any ground, including gender, race, religion, age, sexual orientation, disability, etc.

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