Executive QMS Production (Injectable)

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.

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