Bespak, a Consort Medical Company, is a global market leader in the manufacture of drug delivery devices for pharmaceutical partner Companies, including respiratory, nasal, and injectables products. Bespak have contributed to some of the world’s leading medical devices.
We currently have a requirement for an Operational Quality Engineer to join our Operational Quality team. The purpose of this role is to be responsible for performing quality assurance activities to ensure the interest of customers and stakeholders are met. Also, performing appropriate methodologies to protect and enhance reputation through the mitigation of risk.
- Support the OP QM and QCMS with ensuring that the product streams comply with all relevant internal compliance procedures and specification requirements. Support the OP QM and QCMS with implementing corrective action, as required, to maintain production requirements with minimal impact to the company.
- Support the OP QM and QCMS in assessing and identifying potential product stream risks from internal data, to ensure that any risks are removed or mitigated.
- Participate in product stream change control and CAPA processes in a timely manner, to continually improve the processes.
- Assist with the implementation and verification of corrective and preventive action (CAPA) activities.
- Support the day to day quality activities for the customer interface including; complaint investigations, product specifications, validations and change activities as defined by quality management, ensuring these activities run smoothly.
- Support the day to day activities to ensure suppliers are managed appropriately by activities such as audits, complaint investigations and change implementation.
- Provide proactive expert knowledge in quality requirements to all levels of the business, to ensure that operational functions comply with appropriate GMPS.
- Support and lead, where required, in quality projects as defined by quality management.
ESSENTIAL KEY ATTRIBUTES:
- Educated to ‘A’ level (or equivalent) in a technical discipline.
- Experience of quality assurance within medical device manufacturing.
- Proven problem solving tools and techniques experience.
- Strong influencing and communication skills.
DESIRABLE KEY ATTRIBUTES:
- Detailed knowledge of pharmaceutical legislation.
- Sap knowledge.
- Educated to HND / degree level.
- External auditing experience.
We strive to be an ‘Employer of Choice’ and, in addition to our intrinsic benefits and career and development opportunities, we offer an attractive range of employee benefits, including our Group Personal Pension Plan, Healthcare Scheme, Permanent Health Insurance, an all-employee share incentive scheme, Save as you Earn (SAYE) Scheme and 28 days (plus 8 days Bank Holiday) paid annual leave.
If this sounds like the ideal role for you then we’d love to hear from you. Please apply to Careers@Bespak.com and send us your CV for review.