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Production Compliance Officer

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Fresenius Kabi

14d ago

  • Job
    Full-time
    Senior & Expert Level
  • Consulting
    Legal
  • Chester

AI generated summary

  • You should have extensive pharmaceutical experience, preferably in sterile manufacturing, strong IT skills, and a degree in a scientific field is desirable.
  • You will ensure GMP compliance, develop SOPs, investigate non-conformances, perform audits, analyze data trends, conduct risk assessments, prepare quality reviews, and advise staff on quality standards.

Requirements

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

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

FAQs

What are the working hours for the Production Compliance Officer position?

The working hours are 37.5 hours per week, Monday to Friday, alternating between 7am - 3pm and 3pm - 11pm weekly.

Is experience in sterile manufacturing preferred for this role?

Yes, sterile manufacturing experience is preferred for the Production Compliance Officer position.

What qualifications are required for this position?

Extensive experience in the pharmaceutical industry in a similar role is required. A degree in a scientific field is desirable.

Are there any benefits associated with this role?

Yes, benefits include no weekend or night shifts, a contributory pension scheme, tailored training, life insurance, holiday allowance, and more.

What kind of training and development opportunities are offered?

The company provides a role-specific tailored training and development plan for the Production Compliance Officer.

Will I be responsible for conducting audits in this role?

Yes, performing audits to identify and address non-compliance issues is one of the key responsibilities.

Is there a policy for employees to take maternity, paternity, or adoption leave?

Yes, the company offers maternity, paternity, and adoption leave as part of its benefits package.

Does the company promote diversity in the workplace?

Yes, the company is proud to foster a workplace free from discrimination and values diversity of experience, perspectives, and backgrounds.

Will I need to generate reports as part of my responsibilities?

Yes, the role includes performing trend analysis of data and generating trend analysis reports.

Is this position limited to office work, or are there elements that involve onsite operations?

The role is based in Runcorn and involves onsite operations within the aseptic production team.

Fresenius Kabi

Manufacturing & Electronics
Industry
10,001+
Employees
1912
Founded Year

Mission & Purpose

Fresenius Kabi is a global healthcare company that specializes in lifesaving medicines and technologies for infusion, transfusion and clinical nutrition. The company’s products and services are used for the therapy and care of critically and chronically ill patients. Its product portfolio comprises a range of highly complex biopharmaceuticals, clinical nutrition, medical technologies, and I.V. generic drugs. Within biopharmaceuticals, Fresenius Kabi offers, among others, biosimilar drugs with a focus on autoimmune diseases and oncology. The company’s clinical nutrition offering includes a wide selection of enteral and parenteral nutrition products. In the segment of medical technologies, its offering includes vital disposables, infusions pumps, apheresis machines, cell therapy devices, and more. Fresenius Kabi puts essential medicines and technologies in the hands of people who help patients and finds the best answers to the challenges they face. Following its “Vision 2026”, the company is furthermore committed to increase efficiencies in the therapy and care of patients and improve access to high-quality healthcare around the globe. Fresenius Kabi aspires to be leading globally in its product segments – all for the benefit of patients, its customers, and its stakeholders.