QC Senior Scientist

QC Senior Scientist (1 year Secondment opportunity)

Location: Swindon

Position summary; Monday Friday 37.5 hours per week (Onsite)

We are seeking a motivated and skilled QC Senior Scientist to support QC Release Stability and InProcess Validation activities. This role requires strong analytical expertise excellent attention to detail and the ability to work both independently and collaboratively within a highly regulated environment.

The Role:

• Perform analytical testing for finished product release stability and inprocess validation in line with approved methods SOPs and agreed timelines.
• Conduct analysis using a range of techniques including Balances pH meter UV Karl Fischer FTIR TLC Dissolution HPLC (including degradation analysis) and Coulometric Karl Fischer.
• Troubleshoot basic analytical issues when required.
• Review and report QC Release Stability and Validation data.
• Ensure all analysis is carried out in compliance with company procedures and GMP standards.
• Competent use of Quality Systems including:
  • LIMS: entering/checking results receiving batches stability protocol builds.
  • Qumas: document printing and creation of complex CRs.
  • Trackwise: writing basic OOS/ATR/method deviation reports and proposing effective CAPAs.
• Generate detailed test plans and Analytical Summary Reports for validation projects.
• Write or check stability reports based on defined protocols and generated data.
• Maintain accurate laboratory notebook entries with strong RightFirstTime performance.
• Identify and appropriately investigate outofspecification and outoftrend results.
• Complete deviation investigations and associated FM022 documentation.
• Manage daytoday tasks with minimal supervision.
• Plan workload for yourself and support planning for the wider team as required.
• Prepare and maintain laboratory rotas.
• Implement and influence best practices in laboratory methodology.
• Support 5S laboratory standards and maintain organised work areas.
• Participate in internal audits for equipment and laboratory processes.
• Maintain compliance with EH&S requirements including raising SOS entries and following Risk & COSHH assessments.
• Contribute to LSC activities and uphold corporate policies procedures and behaviours.

The Candidate:

• Strong technical understanding of QC release testing.
• Ability to work independently and as part of a team.
• Confident running HPLC.
• Excellent organisational and timemanagement skills.
• Experience performing Root Cause Analysis using structured techniques
• Proactive approach to problemsolving and continuous improvement.
• Strong communication skills both written and verbal.

Why Join Catalent

• Competitive Salary Reflecting your experience and skills.
• Bonus & Benefits Includes an annual performance bonus a pension scheme matching up to 8% and life assurance. Generous holiday entitlement that increases with tenure and the option to purchase additional leave. Plus gain access to Reward Gateway offering discounts at many national retailers.
• Career Development Access high-quality training mentoring and cross-functional opportunities within Catalents global network. Benefit from a subscription to LinkedIn Learning providing access to 10000 online courses.
• Health & Wellbeing Includes an employee assistance programme on-site canteen facilities and an active safety and Patient First culture. Take advantage of a Cycle to Work Scheme and an Electric Vehicle car scheme. Join Employee Resource Groups that foster a diverse and inclusive workplace. Plus participate in charitable activities.

Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7000 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.

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.

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 and confirming your request for an accommodation and include the job number title and location to . This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local 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.