Catalent Pharma Solutions QA Operations Associate in Dartford, United Kingdom

Job Description

Quality Assurance Operations Associate

As the Quality Assurance Operations Associate at our Dartford site you will be responsible for the adherence and management of quality systems mainly related to product quality in line with cGMP’s and current standard as part of the overall QMS within Catalent Micron Technologies.

The role of Quality Assurance Operations Associate is vital to the sites activities ensuring and will form part of a dynamic Quality team dedicated to providing a top-quality service to our clients with a “Patient First” focus.

The Role

  • You will be responsible for the individual batch record review and release by supervising the activity of pre-contract review and the review of manufacturing and Quality Control (QC) test data.

  • You will also support operations in inspecting, releasing equipment and releasing incoming materials as well as reviewing data and generally any support task that Operations require to continue Production.

  • The role will see you ensure, together with Quality Management Systems Manager that procedures and processes are followed in line with Catalent Micron technologies Quality Manual.

  • Ensure that the services provided meet all regulatory requirements and client quality technical agreements.

  • To support, assure and advice New Product Introduction into the facility in line with good manufacturing process (cGMP) requirements.

  • To safeguard the quality of materials and data handled or processed in accordance with regulatory and cGMPs requirements.

  • Ensure all facilities, systems, equipment, operations and data etc. are all time validated in accordance with cGMP standards and industry expectations.

  • To conduct investigations relative to complaint and deviations and to liaise with the customer and to participate in the corrective and preventative action implementation

  • Assure trending and management of complaints, deviations and KPI’s affecting product quality when required.

The Candidate

  • Senior QA professional with extensive QA experience in batch review

  • Extensive experience of working in an API /Drug product manufacturing site and GMP environment

  • Background in Scientific matter

  • Ability to organise and prioritise work and display an accurate and systematic approach to work.

  • Ability to work unsupervised, be self-motivated and take the initiative to introduce new ideas.

  • Must be customer orientated with good written and verbal communication skills.

  • Thorough knowledge of EU, US and other regulations relevant to Catalent pharmaceutical operations as well as a strong working knowledge of API manufacturing.

Position Benefits

  • Competitive Annual Salary

  • Site Bonus

  • Healthcare

  • Pension Scheme

  • Life Assurance

  • On site canteen

  • Free parking

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.