Executive - Production QMS

Biotech Vision Care

1 - 5 years

6 - 7 Lacs

bavla

Posted:1 day ago| Platform:

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Skills Required

parenteral aseptic production qms injectables bmr review bpr review

Work Mode

Work from Office

Job Type

Full Time

Job Description

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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