Pharmaceutical jobs in United Kingdom

By joining Bio-Techne, you'll join a company with a powerful and positive purpose of enabling cutting-edge research in Life Sciences and Clinical Diagnostics. Bio-Techne, and all of its brands, provides tools for researchers to further treat and prevent disease worldwide.

Bio-Techne is a world-leading developer and manufacturer of high quality life science reagents and is seeking a QA Compliance Officer to join their growing team in their QA department in Bristol.

This successful candidate, reporting to the Quality Assurance and Regulatory Compliance Team Leader, will join a vibrant and dynamic Quality Assurance team covering Quality Assurance tasks to ensure compliance to the QMS and GMP regulations for products manufactured on the Bristol site. This is an exciting opportunity for a QA Compliance Officer to help maintain the current Quality Systems as well as get involved in continual improvement of these systems.

1. Ensuring site compliance with the ISO 9001 QMS, EurdraLex Volume 4 Part II GMP regulations and other applicable legislation, by working closely with internal colleagues from all departments to ensure compliance requirements are recognised, understood and maintained.
2. Assisting with the Quality System internal audits process across Bristol in compliance with ISO 9001 and GMP regulations.
3. Maintenance of the Non-Conformances/Corrective Actions system at the Bristol site, working closely with colleagues from all areas to ensure items are effectively managed and closed in a timely manner.
4. Administration of the Documentation and Change Control processes at the Bristol site.
5. Input into the Customer Product Complaint process for the Bio-Techne Bristol product portfolio.
6. Gathering and analysing Quality Systems data, including assessment against KPIs to ensure the effectiveness of the Bristol ISO 9001 QMS.
7. Responsible for creating, maintaining and continually improving standard operating procedures (SOPs) to ensure compliance is met and maintained.
8. Participate in customer and regulatory audits, including preparation activities, during the audit and any follow up activities.
9. As required, participate in applicable meetings as the QA Compliance representative and serve as a contact for internal and external customer compliance matters for Bio-Techne Bristol products.
10. Conduct QA training sessions for new starters and ongoing refresher training sessions.
11. Ensure that the QA Training Matrix is up to date and training records have been completed as required.
12. Regulatory Compliance activities related to Controlled Drugs.
13. Provide cover for Supplier Quality and QA Batch Release Team, when required.
14. Perform additional duties as assigned.

1. BSc/BA degree in biology, chemistry, biochemistry, bioengineering, or a related life science field.
2. A high level of experience working within a Quality Assurance or Quality Systems function for a Pharmaceutical, Medical Device, Life Science or Biotechnology company.
3. Experience of working within a cGMP environment.
4. Experience of working to EudraLex Volume 4, Part II or to 21CFR part 820.
5. Experience of working to ISO 9001 or ISO 13485.

1. Experienced internal auditor for ISO 9001/ISO 13485 and cGMP.
2. Experienced in investigation of customer complaints and customer technical support.
3. Experience with Customer and Regulatory audits.
4. Experienced in the critical review of CAPA / non-conformances / deviations.
5. Experience of data analysis against KPIs and reporting trends to Top Management.
6. Experienced in documentation management systems and change control processes from a Quality Assurance perspective.
7. Experience of Supplier Quality processes.

1. Excellent team working skills
2. Ability to critically review documentation
3. Methodical, process orientated and highly organised
4. Excellent attention to detail
5. Excellent time management skills
6. Excellent verbal and written communication skills in English
7. Problem solving ability
8. Flexible with a can-do attitude

1. We offer competitive wages along with extensive benefits for employees and their families.
2. We invest in our employees' financial futures through retirement programs and an employee stock purchase plan.
3. We help our employees develop their careers through mentorship, promotional opportunities, training and development, internship programs, and more.
4. We offer an international and diverse working environment, enriched by employee resource groups; volunteer and charity events; and employee events that build a culture of caring and belonging.
5. We foster a culture of empowerment and innovation, where employees feel valued and encouraged to bring their new ideas to the table.

Bio-Techne is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

To protect the interests of all, Bio-Techne will not accept unsolicited resumes from any source other than a candidate application. Any unsolicited resumes sent to Bio-Techne will be considered Bio-Techne property.