United Kingdom – Cambridgeshire
Qualified Person / Quality Assurance Manager
Amgen Quality Assurance team is looking for an experienced Qualified Person who will be the Quality reviewer and approver on Good Manufacturing Practice documentation, providing Quality Oversight whilst partnering with internal and external stakeholders.
If you are looking for your next career step within Quality Assurance and want to be part of our mission – To serve patients – which drives all that we do, apply or get in touch. Take a look at our career pages to find out more about Amgen UK https://careers.amgen.com/where-we-are/en-gb/
Qualified Person role overview:
As an experienced Qualified Person, you may be assigned to a specific Quality functional area in which you will be responsible for Inspection readiness activities, Quality Risk Management, Metric reporting, monitoring and representing the Quality Assurance function at cross-functional meetings and external forums.
As a Qualified person, you will assume a lead auditor capacity and participate in self-inspection program.
- Perform all activities in compliance with Amgen safety standards and SOPs
- Ensure all GMP compliance training is up to date before performing GMP activities and participate in training of new colleagues
- Perform all tasks with due care and attention and in accordance with Good Manufacturing Practices and Amgen requirements, policies and procedures
- Provide Quality direction and input at Change Control and NC Review Boards and assume oversight of change control and NC/CAPA records; ensuring scope of record is clear and implementation activities are robust and timely
- Write, review and approve Standard Operating Procedures in accordance with Amgen Policies
- Participate in site activities associated with QMS programs (e.g., Validation, Complaints, Change Control) and provide active input into shaping the future direction of these systems
- Review and approval of NCs and associated CAPAs for closure ensuring compliance with appropriate documentation, whilst ensuring that CAPA actions address root cause and implementation plan dates are achievable
- Participates in customer complaint investigations
- Provides training and advice to staff
QA Technical Support and Disposition Function (may perform some or all these duties)
- The QP will without prejudice also assume responsibility for the final disposition and certification of product and for ensuring that the batch has been manufactured and checked in accordance with the requirements of the Marketing Authorisation, principles and guidelines of cGMP
- Site Program Owners for site disposition activities, Quality Agreements, Site Master File, Market Action activities and for the provision of subject matter expertise for related programs including, Complaints, Stability and Product Quality Review
- Provide overall quality direction and oversight for key functional areas, Process Development, Validation, Quality Control, Supply Chain, Engineering, Information Systems, ensuring that programs, policies and procedures are robust and in keeping with regulatory and internal expectations
- Act as Quality point of contact and decision maker during Technology Transfer activities whilst ensuring that all activities meet internal and regulatory expectations
- Review and approve validation lifecycle documents, including Master-plans, protocols, reports and active participation during earlier phases of process design, Characterisation, Commissioning etc
- Co-ordinates and approves the preparation of reports for Product Quality Reviews including batch listing and deviation trend reports to ensure that trends are acted upon and to demonstrate that products consistently meet desired critical quality attributes
- Quality SME reviewers/approvers for regulatory submissions, ensuring compliance with site and corporate procedures
- Must satisfy requirements outlined in Directive 2001/83/EC to be eligible to act as a QP
- Degree educated in Science or Engineering related discipline
- Proven experience of working in the pharmaceutical or biotechnology industry or other combination of experience and educational background that may otherwise satisfy the requirements of the role.
Preferred Skills and Qualifications
- Excellent written and verbal communication skills
- Experience working with dynamic cross-functional teams and proven abilities in decision making
- Strong organizational skills, including ability to follow assignments through to completion
- Demonstrated ability in problem solving and experience in managing Root Cause Analysis / Non Conformance /Deviation investigations
- Detailed Knowledge of applicable Regulatory requirements. Experience with Regulatory inspections.
- Experience working in aseptic operations, protein formulation, vial and syringe filling.
Remuneration: Competitive salary & comprehensive benefits package including bonus scheme
Amgen is one of the world’s largest independent biotechnology companies, with global revenue of $23 billion and nearly 20,000 employees globally. For more than 35 years, Amgen has pioneered biotechnology breakthroughs, to bring state-of-the-art medicines from laboratory to the patient. Amgen has not only discovered and developed innovative human therapeutics, but has invested in cutting edge manufacturing capability and support services to deliver these exciting therapies to medical teams around the world.
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