Pharma Jobs at Biotech Healthcare – Apply Now For Executive Post
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About the job
Job Posting: 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 handled
This is an individual contributor role, reporting directly to the AGM, Production.
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