Executive QMS Production (Injectable)

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: https://www.biotechhealthcare.com

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