Catalent Pharma Solutions Quality Specialist II in Bathgate, United Kingdom

Job Description

Quality Specialist II

Quality Specialist II reports to Quality Manager

In the role of Quality Specialist II you will focus on documentation review with a Patient first approach within a Good Manufacturing Practice (GMP) environment. This is a dynamic role within a versatile Quality team that will see you as the Quality Specialist II gain exposure with all areas that Quality team are responsible for. Your role will directly contribute to improving patients’ lives whilst providing a top class service to our varied clients.

The Role

  • Your role will be to review and approve Material Specifications and incoming material products in accordance with Pharmacopoeia and client requirements.

  • You will also be required to review and approve Pre and Post Packaging Batch Records, Pre and Post Qualification documents, Randomisations and event/deviation reports to ensure compliance with GMP, company procedures and client requirements.

  • Compliance management and investigations

  • Liaise with relevant department staff and management on quality issues and timelines

  • Perform internal audits and follow up on recommendations to ensure requirements are met

  • Work to scheduled daily priorities to ensure all commitments are achieved.

The Candidate

  • You will be able to provide evidence of at least 3 years’ experience of Pharmaceutical/Clinical Trials and GMP Processes.

  • Excellent verbal/written communication skills are essential in this role

  • A high level of concentration and a good eye for detail is essential.

  • You must be an adaptable person with the ability to prioritise daily/weekly workload while working independently

  • The ability to be decisive when required on material/product quality issues to ensure compliance is also required.

Benefits

  • Competitive Salary

  • BUPA healthcare

  • Life assurance

  • Pension

  • Free on-site parking

  • Subsidised canteen

  • Free drinks vending

  • Wide range of high street discounts

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.