Sector: Life Sciences
Consultant: Chris Hutchinson
Salary: £90000 - £150000
Job Status: Permanent / Full Time
My client develop, produce and market affordable generic medicines, as well as innovative and specialty pharmaceuticals and over-the-counter consumer healthcare products, along with supplying active pharmaceutical ingredients to nearly 1,000 customers in over 100 countries.1
Today they have a portfolio of more than 1,800 molecules and we produce approximately 120 billion tablets and capsules a year.1
I have an opportunity for a Qualified Person (QP) to join the team in Eastbourne, as a Qualified Person you will perform final QP Batch Release ensuring that all products released to market comply with the requirements of the Manufacturer’s Licence, Marketing Authorisations, and GMP in accordance with Directive 2001/83 EC.
- Act as a Qualified Person in accordance with the duties as defined in Article 51 of the Directive 2001/83 EC and the code of Practice for Qualified Persons.
- Ensure that the principles and guidelines of GMP have been met during manufacturing, packaging and testing operations for all products for which Eastbourne is the named site of batch release.
- Verify that all batch related documentation is compliant with the requirements of the regulatory authorities.
- To review and release batches to market in a timely manner so as not to cause stock outs.
- To ensure the Quality management systems at Eastbourne are maintained and comply with the requirements of GMP.
- To ensure planned changes or deviations are supported by appropriate sampling, inspection, testing, and document review to ensure compliance with the requirements of the regulatory authorities. (Audit, Investigations, Change Control and Deviations permit release of batches to market).
- To ensure planned changes or deviations in manufacturing or quality control have been notified in accordance with a well-defined reporting system.
- To liaise with the relevant Health Authorities in accordance with the Notification to Management process.
- To ensure that manufacturing and testing processes have been validated and all the necessary checks and tests have been performed.
- To ensure appropriate audits, self-inspections and spot checks are carried out by trained and experienced staff.
- To support Health Authority and Third party audits of the Eastbourne site.
- To provide guidance and support for the Eastbourne packaging operations.
- To monitor and enhance (by way of continuous improvement) the Quality Management system.
Qualifications, skills & experience
- Qualified to Degree level or equivalent in Science.
- Membership of appropriate professional body.
- Eligibility to become a QP on UK’s Licenses.
- Proven experience within the pharmaceutical industry with a current Manufacturing Licence.
- Excellent knowledge of and commitment to a systems approach to Quality in Pharmaceuticals.
- Pharmaceutical GMP.
- Experience in MHRA inspections.
- Demonstrable and proven track record in leading the introduction of change.
- Proven ability to plan resources and manage priorities to consistently deliver on time against tight project timelines.
- Well-developed communication skills with the ability to persuade and influence all levels of colleagues, regulators and industry specialists.
- Hold the highest standards of integrity, especially in decision making and the application of standards.
- Evidence of continuing professional development such that knowledge, understanding, and experience is maintained and current.
- Ability to influence effectively.