Plant QA Manager 247
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Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
Career Category
QualityJob Description
Plant QA Manager Responsibilities
Responsible for leading and directing a team on 24/7 shift including managing their performance and supporting their development.
Provide real-time QA oversight and support for production operations. This currently extends to formulation vial and Syringe Fill Finish aseptic operations and visual inspection.
Collaborate with operations to resolve quality and compliance issues including but not limited to Change Controls NCs and CAPAs.
Ensures that changes that could potentially impact product quality are assessed according to procedures (ex: site change control maximo)
Review and approve cGMP records (e.g. Non Conformances CAPAs electronic batch record change controls design qualifications SOP etc.) ensuring compliance with appropriate documentation
Alerts senior management of quality compliance supply and safety risks
Support and represent Quality during audits and inspections
Support Lean Transformation and Operational Excellence initiatives
Provides training and advice to staff in order for them to perform their desired functions.
The knowledge and skills necessary to perform the duties of the QA Manager are typically acquired through the following combination of education experience and knowledge.
Basic Qualifications
University degree. Engineering or Science related discipline preferred.
Relevant experience (8yrs ) working in the pharmaceutical or biotechnology industry or other combination of experience and educational background that may otherwise satisfy the requirements of the role.
Technical skills and demonstrated competencies across a broad range of quality related disciplines.
Preferred Qualifications
Experience working in aseptic operations protein formulation vial and syringe filling.
Demonstrated ability in problem solving and experience in managing Root Cause Analysis / Non Conformance /Deviation investigations
Experience working with dynamic cross-functional teams and proven abilities in decision making
Experience in management or leadership roles
Detailed Knowledge of applicable Regulatory requirements. Experience with Regulatory inspections.
Excellent written and verbal communication skills
Strong organizational skills including ability to follow assignments through to completion
Required Experience:
Manager
Key Skills
- Quality Assurance
- FDA Regulations
- Food Industry
- Food Safety Experience
- ISO 9001
- Quality Systems
- Food Processing
- Quality Control
- Quality Management
- QA/QC
- Selenium
- HACCP
About Company
Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. As an organization dedicated to improving the ... View more
