Job Description
Job description:
*Do you pride yourself on your integrity? We do what's right for employees, patients and partners, and so can you.*
Oxford Biomedica's Quality Assurance (QA) team is responsible for the company's quality processes and systems, in compliance with GMP, GLP and GCP guidelines. The team are accountable for internal and external audits, quality compliance and control.
We are currently recruiting for a Team Leader to manage a team of Senior QA officers and QA officers. The role will also require you to lead, co-ordinate and perform the day-to-day QA Operation activities and tasks, to meet the scheduled timelines in line with manufacturing and supporting function activities whilst ensuring regulatory compliance and industry expectations.
*Your responsibilities in this role would be:*
* Lead and be accountable for the performance of a team of Senior QA officers and QA officers.
* Resource plan and maintain visibility of the team's workload, ensuring completion of activities assigned to direct reports to achieve team and business goals
* Coordinates daily team workload & serves as first point of contact to other OXB departments/stakeholders
* Reviewing / auditing documents generated during the Manufacturing, Quality Control, Engineering, Validation, Warehouse & Supply Chain GxP processes
* Writing, reviewing and approving SOPs, Risk Assessments, Deviation, Change Control & CAPA records.
* Proactively identifying improved ways of working within QA Operations & the wider QMS / PQS
* Supporting Manufacturing, Quality Control, Engineering, Validation, Warehouse & Supply Chain teams by providing Quality Assurance input and guidance on regulatory requirements and industry expectations
* Assuring compliance to EU and US FDA GxP, Company QMS and QA GMP Operations and any other applicable regulations / standards
* Ensures that team's work complies with cGMP, Data Integrity & Good Documentation Practices
* Assist in preparation of areas and QMS processes for inspections (Regulatory, Client and internal)
* Participation in regulatory and client GMP audits and internal Self Inspection program
* Participation in Client projects and programs
* Providing Leadership, coaching, performance feedback and training to all direct reports
* Back up/deputise for QA Operations Manager
Profile description:
*To be successful in this role, you will have the following skills and experience:*
* Science based degree.
* Substantial experience working in a pharmaceutical quality function
* Experience of working within a Sterile / Aseptic GMP manufacturing environment is preferable.
* Very good knowledge of the principles and guidelines for GMP/Regulatory requirements
* Leadership and Management of small teams
* The ability to lead, perform and train QA *processes.*
* The ability to participate in Regulatory / Customer Audits. Experience with client interaction
* Thorough understanding of equipment qualification and process validation.
* Strong IT skills, including MS Office - Word, Explorer, Excel, Access, Outlook.
* Thorough understanding of equipment qualification and process validation.
*Do you want to feel inspired every day? We're future-focused and our business is growing rapidly. We succeed together through passion, commitment and team work, and so can you.*
*Collaborate. Contribute. Change lives*
No Agencies please
We offer:
We are committed to offering highly competitive reward packages for all our staff. That's why, every year, we benchmark our salaries and benefits against the local pharmaceutical market - by that, we mean that we compare our packages with those of other major companies in the London, Oxford, Cambridge areas.
We're looking for highly skilled, focused individuals to help us deliver life-changing therapies to patients. It's no mean feat, and we have to work together to make this happen.
Along the way, you'll have a rich variety of opportunities to really develop your career. We'll also give you a generous set of employee benefits and a competitive salary.