Quality Systems Specialist
THE POSITION
Boehringer is a global company that has a strong purpose; positively impacting the lives of millions, the planet, our communities and of course, positively impacting the health of people and animals.
We are hiring for a Quality Systems Specialist to join a well-established team. The individual will work proactively as part of the site Quality Systems team with all general aspects of GMP and compliance. Take ownership for, maintain & develop QMS processes and proactively coach and reinforce the quality culture across all site functions. This position interfaces with all areas of Manufacturing, support functions and the Quality Unit.
This is a hybrid role based in Pirbright requiring 3 days onsite, 2 days work-from-home arrangement.
TASKS & RESPONSIBILITIES
Responsible to own at least one Quality System as Local Management System Owner
• Maintains Quality System in accordance with current regulations and in alignment with Boehringer Corporate and Global BioPharma standards. Reports quality process performance
• Escalation of Quality System topics via Tier system, Quality Management Review and Senior Leadership Team
• Work with Divisional and Global counterparts in continuously improving the local system processes, including facilitation of site visits
Local Documentation Management in both electronic and paper formats
• Workflow management, ensuring compliant record management and good documentation practices are followed
• Document archiving
• Ensures adherence to global document lifecycle requirements including data integrity governance & retention policies
Local Training Management
• Management of training matrices, training schedules and classes
• Curricula generation & assignment, delivering training, documenting & recording training of learners
Generation and communication of local Quality System KPI's
• Provide and present metrics for monthly and quarterly local and divisional Quality Management Review
• Record, report and track relevant data for owned systems
Support the Quality Systems Team & local site with compliance topics
• Participate and support with regulatory inspections, global quality audits and local internal audits
• Support Boehringer Pirbright Operational Teams with Quality Systems administrative tasks, topics and enquiries. Including but not limited to Discrepancies, CAPAs, Change Controls, documentation review and approval
• Provide input into the local site Quality Risk Management programme. Promote a risk-based approach to the handling of Quality Events, Process Implementation, Process Improvements in accordance with regulatory guidelines
REQUIREMENTS
• A minimum of 5 GCSE (or equivalent) passes inclusive of English and Mathematics. Science related A levels/equivalent
• Strong knowledge of the principles of EU Good Manufacturing Practice (GMP) and Quality Assurance/Systems
• Excellent written and verbal communication skills
• Ability to work collaboratively across functions; form constructive relationships with staff and Corporate Representatives at all levels
• Ability to deliver training. Desirable: Knowledge of training, coaching, principles of learning
• Experience of working with QMS processes applicable to a GxP Pharmaceutical manufacturing environment
• Ability to utilise computer programs such as Microsoft word, Excel, Power Point, Power BI, Outlook, off the shelf/custom built GMP software, and eQMS systems
WHY THIS IS A GREAT PLACE TO WORK
Boehringer Ingelheim has been recognised as a Top Employer in the UK. Being certified as a Top Employer confirms our dedication to a better world of work, delivered through excellent HR policies and people practices. To learn more visit: https://www.boehringer-ingelheim.co.uk/careers/uk-careers/why-great-place-work