Quality Specialist II

Quality Specialist II

Location; Bathgate UK

Position Summary; Onsite role Monday Friday 37.5 hours p/w.

As a Quality Specialist II you will support the sites Quality (GMP) objectives and policies ensuring quality systems and processes operate to the required standards. You will provide QA expertise across packaging and materials operations working closely with crossfunctional teams to ensure compliance with GMP pharmacopoeia client and regulatory requirements.

The Role:

• Managing the movement control and tracking of GMP documentation to support production schedules
• Reviewing and approving material specifications incoming bulk intermediate and finished materials
• Reviewing and approving GMP documentation deviations and observation reports
• Performing internal audits monitoring and trending audit findings
• Conducting QC inspections and sampling of products and materials
• Performing receipt inspection and approval of blank label stock
• Taking and controlling reference samples for packaging components preprinted materials and devices
• Approving or rejecting packaging components preprinted materials and medical devices
• Creating material specifications for inprocess visual inspections where required
• Supporting additional quality checks requested by clients QA or Operations
• Verifying shipments against client documentation and approved specifications
• Recording communicating and closing supplier issues including CAPAs and effectiveness checks in a timely manner

The Candidate

• BSc in a relevant scientific discipline or equivalent experience within a pharmaceutical environment or equivalent technical knowledge
• Experience working within Quality Assurance either Pharmaceutical or Clinical Trials
• Excellent verbal and written communication skills
• High level of attention to detail and concentration
• Strong analytical and problemsolving skills

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.