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Operations Quality Specialist
3 weeks ago
Job Title: Operations Quality Specialist
About the Role:We are seeking a skilled Operations Quality Specialist to join our team. The successful candidate will provide direct quality support to a production area as part of a quality integrated product team.
Main Responsibilities:- Review process documentation/data for accuracy, completeness, and data integrity compliance.
- Approve new and updated master batch records/electronic batch records.
- Ensure accuracy and compliance with cGMPs and company procedures for executed electronic batch records and logbooks.
- Review and approve new and updated SOPs/work instructions and controlled job aides.
- Support QA activities including commissioning and qualification lifecycle documents for capital projects and new equipment.
The Operations Quality Specialist will serve as a quality subject matter expert (SME) for performance qualification (PQ) activities across the site. This includes equipment, facility, and utility PQ studies, cleaning validation, SIP, process validation, change management, deviations, CAPAs, equipment requalification, and periodic review, site maintenance & calibration program.
Requirements:- Gained experience in quality operations or a related field.
- Ability to work independently and collaboratively as part of a cross-functional team.
- Familiarity with cGMPs and quality regulations.
This is an excellent opportunity for a motivated and detail-oriented individual to develop their skills and contribute to the success of our organization.
Benefits:We offer a competitive salary package, opportunities for professional growth and development, and a dynamic working environment.