Deputy RP

As Deputy Responsible Person (RP) position ensures the oversight of Catalent Third Party manufacture and Packaging activities in the absence of RP. The position also requires the applicant to perform the required activities as Deputy Responsible Person for the authorization of Catalent for the import, export, and foreign trade of medicinal products.

The position will perform supplier qualification initiatives, continuous improvement, supplier performance. And quality and regulatory compliance at the Cham facility in the absence of RP.

The main Deputy RP responsibilities are the following:

Specific Duties, Activities, and Responsibilities (In absence of RP):

• The Deputy Responsible Person (RP) has the authority to make decisions related to GDP compliance, operates with sufficient independence to ensure compliance with regulatory requirements, and has direct access to senior management for quality- and compliance related matters in the absence of RP.
• Deputy Responsible Person for import, export, and foreign trade pursuant to Art. 15, Art. 16, Art. 17, Art. 18, Art. 22, Art. 23 of the Medicinal Products Licensing Ordinance (Arzneimittel-Bewilligungsverordnung “AMBV”; Classified Compilation of Federal Legislation “SR” 812.212.1).
• Function as assisting GDP contact person for authorities and assist inspections by Regulatory Agencies, e.g., Swissmedic.
• Deputy Responsible for the quality of the Cham facility in interaction with other Catalent sites and ensure the proper handling of medicinal products.
• Ensure that the medicinal products are distributed in compliance with the requirements under the Good Distribution Practice (GDP).
• Contact between Third Parties and customers on Quality related activities, to ensure positive customer experience and relationship management.
• Maintain and oversee the Quality Management System (QMS) related to GDP activities in the absence of RP.
• Approve and maintain GDP-related SOPs, policies, and procedures.
• Ensure that GDP training is provided, documented, and maintained for all relevant personnel.
• The Deputy RP role requires an initial and continuous training in pharmaceutical distribution and GDP compliance trainings on a regular basis.
• Manage and assess deviations, CAPAs, complaints, and recalls related to distribution activities. Review of QMS documentation (Complaints, Deviations, Change Control) before providing to the Customer.
• Monthly reconciliation of Pharmacovigilance Individual Case Study Report for Third Party.
• Collaborate and foster cross-functional business relationships with other functional groups such as Procurement and Supply Chain.
• Manage quality initiatives, generate routine performance metrics and assessments using risk-based methods.
• Monitor and facilitate activities required to assure qualified status of existing and prospective suppliers in compliance with Global procedures and Regulatory requirements.
• Ensure qualification and ongoing compliance of suppliers, service providers and transport partner activities, and audits as required. Support the Global Internal Audit Compliance Program as necessary.
• Ensure proper documentation and record retention in line with regulatory requirements.

Manage follow-up activities to external audits including identification of root cause, risk assessment, and providing feedback on potential resolutions.

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.

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Catalent is an Equal Opportunity Employer, including disability and veterans.

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 [email protected]. 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.

Important Security Notice to U.S. Job Seekers:

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