Validation Associate

3 months ago

Dartford, United Kingdom Catalent Full time

At our Dartford site (CMT) our mission is to be the industry choice for high potent, high value API micronization. Today, we supply ~40 micronized product to a wide range of customers and patients​. We’re committed to a culture of continuous improvement and people development so everyone at the site can grow and thrive.
 

Catalent Dartford require a Validation Associate to join our team. The Validation Associate will work as part of the QA team on the full scope of Pharmaceutical Validation processes. They will have ownership and be responsible for the validation activities on site including equipment, facilities, utilities and laboratory computer systems validation.

The Role:

Accountable for generation and maintenance of the site Validation Master Plan and validation of documents including schedule, plans, protocols, reports and exceptions liaising with other functions as necessary. Organise and co-ordinate equipment validations e.g. new lab instrumentation, new operations equipment, temperature mapping of warehouse. Participate in Validation History Reviews for systems to ensure validation practices are in compliant with the most up to date regulatory requirements. Reviewing Process and Analytical Development reports and other supporting documentation relating to the new Products, or changes to existing products and assessing their suitability for Validation and Review performance of products throughout the year and write / contribute to Product Quality Reviews (PQR / APR's). Provide technical / validation guidance in assessment of process deviations with respect to equipment performance and impact on product quality. Write or amend Batch Manufacturing Records as required when directly related to Validation activities for existing products. Systematically reduce risks to employees, products and the environment through proactive risk assessment and rigorous EHS&S investigations. Manage a Quality Management system (i.e training, SOP, internal audit, approval of SOPs, site master file, document archiving, site/corporate metrics, supplier management, validation) at the site in line with cGMP’s requirements and Catalent standards. Completion of GMP documentation (e.g., BMRs) in accordance with Data Integrity requirements.Completion of deviation and complaint investigations on time with appropriate CAPAs.

The Candidate:

Required: Graduate in Pharmaceutical Sciences or equivalent experience Experience in leading validation in a cGxP environment, with strong working knowledge of the regulations and legislation relating to cGMP Experience of management of multiple projects Experience of executing validation protocol Experience of working in a cGMP environment

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. 

personal initiative. dynamic pace. meaningful work.

Visit 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.

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