Logo of Huzzle

Home

Matches

Explore

Manage

Production Compliance Officer

image

Fresenius Kabi

1mo ago

  • Job
    Full-time
    Senior Level
  • Chester

AI generated summary

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

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, with shifts alternating weekly between 7am - 3pm and 3pm - 11pm.

Is experience in sterile manufacturing required for this role?

While extensive experience in the pharmaceutical industry is required, sterile manufacturing experience is preferable.

What qualifications are necessary for this position?

A degree in a scientific field is desirable, along with extensive experience in a similar compliance role within the pharmaceutical industry.

Are there opportunities for career advancement in this role?

Yes, this position is designed for individuals looking to advance their careers within the pharmaceutical industry.

What benefits are offered to employees in this position?

Benefits include no weekend or night shifts, a contributory pension scheme, life insurance, generous holiday allowance, professional fees paid, and various employee support programs.

Will I need to conduct audits in this role?

Yes, performing audits to identify and address non-compliance issues is a key responsibility of the Production Compliance Officer.

Is prior experience in compliance roles necessary?

Yes, extensive experience in a compliance role within the pharmaceutical industry is essential for this position.

Does the company offer training for this role?

Yes, a role-specific tailored training and development plan will be provided to employees.

Are there opportunities for work-life balance in this role?

Yes, the company offers a schedule without weekend or night shifts, contributing to a better work-life balance.

How does the company view diversity and inclusion?

The company is proud to foster a workplace free from discrimination and values diversity of experience, perspectives, and backgrounds. Applications are given fair consideration regardless of identity.

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.