DUTIES AND RESPONSIBILITIESRole DescriptionPerform review and assessment activities of manufacturing documentation to ensure compliance with applicable quality requirements and timely batch disposition and release.
KEY DUTIES AND RESPONSIBILITIES
- Review Batch Record Reports generated by the Manufacturing Department for completeness, accuracy, and compliance with Quality Assurance requirements, and perform preliminary approval.
- Ensure Batch Record Report reviews are conducted in accordance with approved procedures and within established timelines.
- Assess deviations initiated by operational departments and verify the status of any ongoing deviations within API and Finished Product manufacturing areas prior to batch approval.
- Conduct periodic internal inspections to verify compliance with current Good Manufacturing Practices (cGMP) in API manufacturing areas and warehouse operations.
- Participate with the Quality Oversight (QO) Lead in conducting internal audits of manufacturing departments and support the preparation of audit reports.
- Print and issue manufacturing documentation required to support production activities.
- Support the QO Lead in the management of batch records, investigations, and deviations during manufacturing operations.
QUALIFICATIONS EDUCATION
- High School Diploma required.
- Bachelor's Degree in Chemistry, Pharmaceutical Chemistry and Technology (CTF), Biological Sciences, or a related scientific discipline preferred.
EXPERIENCE
- Knowledge of Quality Management System (QMS) principles and quality governance processes.
- Understanding of manufacturing processes, laboratory workflows, and manufacturing support services.
- Thorough knowledge of Good Manufacturing Practices (GMP), site procedures, and corporate quality standards.
- Good command of written and spoken English.
CORE COMPETENCIES
- Strong knowledge of GMP regulations and compliance requirements.
- Effective communication and interpersonal skills.
- Ability to independentl
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