Medical & Health
- To provide QA guidance and support in the production area at ABR.
- To perform batch record review of batches assembled, packaged and labeled at ABR and contract manufacturers.
- To establish effective working relationships with Production, Warehouse, Maintenance and Engineering, QA Management and the Qualified Person
- Provide daily guidance and support to Production staff in regards to compliance with Standard Operating Procedures and Work Instructions.
- Act as a first point of contact in case of production queries (quality related) during packaging and labeling operations.
- Review and approve batch production record data entries before production activities take place
- Perform finished product checks during (commercial) production runs
- Compile and review batch records for lots assembled, packaged and labeled at ABR and contract manufacturers in preparation for disposition by QP.
- Act as author for operational SOP’s and Work Instructions
- Review of operational SOP’s and Work Instructions
- Review and approve deviation records
- Initiate and own QA deviations as needed.
- Approve Maintenance Work Orders
- Review and approve test protocols before use in production
- Perform GMP compliance checks in production
- Assist in development and delivery of GMP training activities for QA and production staff
- Participate in QA production related projects as needed
- Assist in various investigations as needed
- Assist in ABR projects and improvement efforts as needed
- Responsible for preparation of weekly/monthly metrics
- Own and maintain departmental performance boards
Amgen's mission is to help patients. Every day we are committed to improving the lives of seriously ill people. We do this through pioneering scientific research, the development of effective medicines and our focus on the outcome of the treatment.
- Understanding and application of principles, concepts, theories and standards of technical/scientific field
- Specialized knowledge within own specialty area
- Deepens technical knowledge through exposure and continuous learning
- Knowledge of related regulatory/industry considerations, compliance issues and/or scientific discovery
- Applies research, information gathering, analytical and interpretation skills to problems of diverse scope
- Ensures compliance within regulatory environment
- Develops solutions to technical problems of moderate complexity
- Screens, categorizes, evaluates, reconciles, reports and resolves data integrity issues
- Interprets generally defined practices and methods
- Works under general direction
- Work is guided by objectives of the department or assignment
- Refers to technical standards, principles, theories and precedents as needed
- May set project timeframes and priorities based on project objectives and ongoing assignments
- Recognizes and escalates problems
- Contributes to work group/team by ensuring the quality of the tasks/services provided by self
- Contributes to the completion of milestones associated with specific projects or activities within own department or workgroup
- Provides training/guidance to others and acts as a technical/scientific resource within work group/team
- Establishes working relationships with others outside area of expertise
- Mbo or Bachelor’s degree in Life Sciences or related field or the equivalent combination of education and/or experience
- Typically 3 years of related Quality Assurance or manufacturing experience in the pharmaceutical or medical device industry with experience in batch record review and investigations
- Good Manufacturing Practice (GMP), Good Distribution Practice (GDP) and/ or Good Clinical Practice (GCP) knowledge with the ability to interpret and apply in mainly routine cases
- Manufacturing and/or Quality analytical processes and operations
- Fluent in English language