Production Compliance Officer

at  Fresenius Kabi Limited

Overview:
If you have extensive experience in the Pharmaceutical industry within a compliance role and you’re looking for somewhere you can advance in your career, this could be the perfect opportunity for you!
You will be an integral part in providing each individual patient with customised Parenteral Nutrition, whether they are critically or chronically ill. The main purpose of a Production Compliance officer is to develop, implement, maintain and continuously improve quality standards and systems to ensure that all applicable company operations and processes conform to the principles of compliance in the aseptic unit.
This role will be 37.5 hours per week Monday-Friday. The working hours are 7am - 3pm, alternating with 3pm - 11pm on a weekly basis and it will be based in Runcorn.

Responsibilities:

• Support the aseptic production team in the development, implementation and maintenance of GMP standards
• Develop and implement all necessary SOP’s and systems to ensure the effective monitoring of quality standards in accordance with GMP
• Investigate the root cause(s) of non-conformances and identify and ensure implementation of corrective / preventive actions to reduce non-conformances
• Perform audits to support the identification, action and close out of non-compliance issues and support continuous improvement of the QMS within the aseptic production team
• Perform trend analysis of data and generate trend analysis reports
• Conduct risk assessments and gap analysis of the current quality systems and generate appropriate actions plans
• Prepare and complete product quality reviews to ensure compliance with regulatory requirements
• Provide advice and guidance to managers and staff in areas of GMP / ISO9001 and other applicable Quality rules and regulations

Qualifications:

• Extensive experience in the pharmaceutical industry in a similar role
• Sterile Manufacturing experience preferable
• Strong IT skills
• Degree Qualified (Scientific) – desirable

Benefits

• No rota’d weekend working and no night shifts
• Contributory Pension Scheme (rises with service)
• Role specific tailored training and development plan
• Life Insurance (4 x salary, death in service)
• 25 days holiday (rises to 27 after 5 years service) and ability to buy/sell holidays
• Maternity, Paternity and Adoption Leave
• Professional fees paid
• Bike to work scheme
• Long Service Awards
• Employee Assistance Programme
• Free onsite parking and subsidised canteen
• Blue Light Card
• Charity Fundraising & Volunteer Days
• Company funded family days out

We are proud to foster a workplace free from discrimination. Diversity of experience, perspectives, and background create a better work environment and better products. Whatever your identity, we will give your application fair consideration.

• Support the aseptic production team in the development, implementation and maintenance of GMP standards
• Develop and implement all necessary SOP’s and systems to ensure the effective monitoring of quality standards in accordance with GMP
• Investigate the root cause(s) of non-conformances and identify and ensure implementation of corrective / preventive actions to reduce non-conformances
• Perform audits to support the identification, action and close out of non-compliance issues and support continuous improvement of the QMS within the aseptic production team
• Perform trend analysis of data and generate trend analysis reports
• Conduct risk assessments and gap analysis of the current quality systems and generate appropriate actions plans
• Prepare and complete product quality reviews to ensure compliance with regulatory requirements
• Provide advice and guidance to managers and staff in areas of GMP / ISO9001 and other applicable Quality rules and regulation