Senior Lead Quality Officer - Nottingham, United Kingdom - Catalent

Catalent
Catalent
Verified Company
Nottingham, United Kingdom

4 weeks ago

Tom O´Connor

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Tom O´Connor

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Description
Catalent Nottingham are seeking a
Senior Lead Quality Officer to join a Commercial Product franchise team.


This department specializes in commercial products for women's health and the Quality function has the responsibility for all aspects related to Quality Systems, including Finished Product Batch Release, and Change Control.


The primary responsibility of this position is to ensure completion of quality deliverables, for the customer, in order to meet product release and project timelines within the client expectations and, ensuring that the delivery is in accordance with Regulatory and customer requirements, and provide support/deputise for the QA manager when required.


The Role, but not limited to

  • To ensure manufacture has been carried out in accordance with Good Manufacturing Practice
  • Responsible for the review of commercial batches to include batch record approval, compliance to the product MA, and any deviations/changes approvals are completed ready for final release.
  • Review and approve Analytical documents, to include specifications, stability protocols/reports, Analytical methods, OOS documentation.
  • To check if any deviations or planned changes in production or quality control have been authorised by the persons responsible in accordance with a defined system.
  • To verify that the all the necessary checks and tests have been performed, including any additional sampling, inspection, tests or checks initiated because of deviations or planned changes
  • Provide Quality Support to the Supply Chain team to ensure that project deliverables are completed to the required standard. Provide advice and guidance as required to help in meeting legislative requirements and Customer expectations.
  • Work within the Quality team to ensure that Customer projects are delivered to agreed quality standards and meet Customer specifications within agreed deadlines.
  • Proven experience in a GMP Environment, within a Quality Assurance function.
  • Graduate, preferably in Chemistry, Pharmacy or Biological Science.
  • Wide ranging and up to date technical knowledge and experience within the pharmaceutical industry (essential).
  • A good track record with the FDA, MHRA, EMEA and other regulatory agencies, ideally with MHRA facing experience
  • Substantial previous Quality Assurance experience
  • Up to date understanding of regulatory expectations
  • Excellent scientific and technical knowledge
  • Hybrid working option with minimum of two days per week required at site essential.

Position Benefits

  • Annual discretionary bonus scheme based on company and personal performance.
  • Private Healthcare insurance.
  • Health Shield cash plan.
  • Pension
  • 24 days annual leave plus 8 public holidays per annum.
  • Health and wellbeing advice with an Employee Assistance Programme.
  • Free parking
  • Life cover.
  • Flexible working.
  • Gympass
  • Access to a wide range of discounts and benefits on a variety of high street and online shopping

Catalent offers rewarding opportunities to further your career Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.

Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve.

As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone's safety.

The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.

personal initiative. dynamic pace. meaningful work.

Visit Catalent Careers to explore career opportunities.

Catalent is an Equal Opportunity Employer and does not discriminate based on any characteristic protected by local law.
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