Catalent Pharma Solutions Quality Assurance Officer in Bolton, United Kingdom

Job Description

Quality Assurance Officer

As a Quality Assurance Officer, you will be required to review SOP, batch documentation and checklists following the submission by Pre production. You will work in a dynamic team setting who undertake vital quality activities to the wider business.

The Role

  • Work within the quality management systems to maximise quality and efficiency and ensure compliance with current regulations for all medicinal products managed/packed by the facility.

  • Manage the supplier audit schedule, generate supplier audit documentation and agreements, coordinate and participate in external audits.

  • Coordinate, write and manage to completion customer complaints, deviations, Corrective and preventative actions (CAPA’s) and change controls, ensuring proper root cause analysis, prompt responses/resolution and ongoing data evaluation to ensure any emerging trends are acted on.

  • Collate data on aspects of the quality management system for incorporation into regular periodic reports.

  • Participate in the internal audit programme to ensure continued cGMP compliance of all site activities.

  • Participate in Customer audits to explain activities performed and systems managed.

  • Organise and participate in internal quality related training sessions and co-ordinate training requirements within the QA department.

  • Generate/assist in the generation, review or approval of other technical documents ie batch documentation, supplementary packing specifications, material specifications, qualification documentation, validation documentation, technical agreements.

The Candidate

  • Preferable experience within the Pharmaceutical industry and knowledge of key quality systems including auditing/inspection, deviation/complaint handling, qualification.

  • Educated to degree level or equivalent.

  • Confident communicator able to challenge and question submitted documentation

  • High attention to detail

  • Strong interpersonal skills

About Catalent

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. More products. Better treatments. Reliably supplied. ™Visit www.catalent.com/careers to explore career opportunities.

Catalent is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected veteran status. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email along with the job number and title to Jobs@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be routed to a recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you

Catalent offers rewarding opportunities to further your career – join the global drug development and delivery leader! You will help develop some of the nearly 200 products we launch each year or help supply some of the over 7,000 products for patients around the world. Our highly skilled, dedicated global team of over 9,500 is passionate about improving the health of patients by combining their personal expertise with advanced technologies to advance science and supply innovative new products of the highest quality to patients globally.

Why Catalent?

  • Gain unparalleled experience by working on multiple products and technologies – we launch nearly 200 new products for our customers each year.

  • We have 20 global pharmaceutical Product Development teams on five continents, who are, at any given time, working on over 700 new products and hundreds of ongoing clinical trials.

  • Our products include some of the latest life-saving medicines as well as some of the most well-known consumer health brands used by families every day.

  • Catalent’s more than 30 global facilities on 5 continents manufacture over 70 billion doses of over 7,000 important medicines and consumer health products.

  • Nearly 1 in 20 doses of medicines taken around the world has been touched by the Catalent team.

  • We have +1,100 patents on many superior patient-preferred technologies used by all the top pharmaceutical, biologic and consumer health companies.

  • We established the Catalent Applied Drug Delivery Institute to drive collaboration and scientific exchange among industry professionals, academics and partners.

  • Many of our 1,400+ scientists are regularly published in top industry journals and present at top industry conferences to advance knowledge sharing and the development of better life-saving medicines.

Catalent is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected veteran status. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email along with the job number and title to Jobs@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be routed to a recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.