Catalent Pharma Solutions Manufacturing Manager (f/m) in Baden, Germany
Functional and disciplinary leadership of the department production. Coordination of human resources and promotion, qualification and training of subordinate employees (education and training, training, etc.).
Responsibility for the production of pharmaceuticals and nutritional supplements convey; Monitoring and ensuring compliance with international and national legal requirements by AMG, EU GMP Guide and FDA Regulations.
Ensuring a smooth and cost efficient production process and its permanent optimization. Budget planning for property, investment and personnel costs.
Creating and sharing the PI according to § 13 AMWHV, the batch, validation and qualification documentation in manufacturing. Ensuring compliance with instructions (in cooperation with the QP). Ensuring compliance with packing instruction, regular review and adjustment according AMWHV. Creating test and / or release of SOPs and other regulations and documents.
Responsibility for the maintenance and creation of maintenance documents of manufacturing machines, equipment, rooms and other equipment in the area of production. Ensuring the qualification of equipment, facilities and premises for manufacturing and R & D. Responsible for the HVAC system (Heating, Ventilastion, Air Conditioning) and the water system by AMG as operator of the water system.
Ensuring and monitoring the health conditions in the Department of Production.
Coordination and handling of all administrative matters including the conversion of official orders for the department production. Participation in and support of customer audits in the house. Handling customer complaints and cause disposal (in cooperation with the Department Quality). Implementation of CAPA (in cooperation with the Department Quality)
Assistance in obtaining new business (participating in customer visits - both internally and externally)
Catalent Pharma Solutions is the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products. With over 80 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable clinical and commercial product supply. Catalent is headquartered in Somerset, N.J. For more information, visit www.catalent.com
More products. Better treatments. Reliably supplied.™
Catalent is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected veteran status.
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 along with the job number and title to Jobs@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be routed to a 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.
Organization: Drug Delivery Solutions (DDS)
Title: Manufacturing Manager (f/m)
Requisition ID: 0019820