Quality Assurance Manager (FTC)

Job title:

Quality Assurance Manager (FTC)

Company

Catalent

Job description

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 is currently recruiting for a Quality Assurance Manager (FTC) to join our Dartford site. The QA Manager will perform various Quality activities to support the running of the Quality Management System. They will also support the supplier and material assurance programs and wider QMS team.The Role:

• Accountable for effectively managing the people and company resources, including the safety, quality, and compliance, in the designated zone of responsibility and the effective performance management and development of all team members in line with a clear team plan.
• Accountable for achieving the targets and objectives for the area of responsibility, through effective process management, planning and control of resources and driving compliance and continuous improvement of policies and standards across the Dartford site: training, internal/supplier audit, Quality and Technical agreement management, SOP’s, regulatory and compliance trends.
• Management of team members of which ~50% of hours are worked are outside core office hours – requiring a high degree of self-reliance and ability to assess the impact of non-standard safety and/or quality events.
• Ownership of site regulatory and compliance activities.
• Aware of 0 – 18 month production horizon and input into supply chain planning process.
• Aware of site and supply chain performance and role in influencing performance measures (e.g., %OTD).
• Requirement to liaise and interface with a wide range of support functions including Operations, QC, Engineering, Customer Services, Technical Services, etc.
• To embed an EHS&S culture within Quality Assurance and manage the department EHS&S dashboard to meet or exceed targets and to systematically reduce risks to employees, products and the environment through proactive risk assessment and rigorous EHS&S investigations.
• Actively lead continuous improvement within the team, e.g., ensuring effective RCAs are performed, thinking critically to assess requirements and select “best fit” approaches which balance requirements / company objectives.
• Establish, promote and reinforce continuous improvement and “The Catalent Way” (e.g., visual management, tiered meetings, problem solving, QA standard work, leader standard work, 5S, Zoning, process controls, Gemba & process confirmation, etc)
• Deliver the daily / weekly / monthly operational targets by effectively managing the use of resources (facility, equipment & personnel) within designated zone of responsibility.

The Candidate:

• Experience managing/leading a team.
• Required: Graduate in Pharmaceutical Sciences or equivalent
• Experience in a Quality Assurance GxP environment, with strong working knowledge of the regulations and legislation relating to cGMP.
• Role requires technical understanding, advanced problem solving and solution development skills.

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.

Expected salary

Location

Dartford, Kent

Job date

Sun, 26 Jan 2025 01:04:56 GMT

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