Сряда, 26 Юли 2017 г.
новини от последните 24 часа: 945
Contract Manufacturing Operations Manager/CMO Manager in WYSER

Our client is one of the global integrated pharmaceutical companies, currently expanding its organization and creating a division to support Third Party Operations (TPO). We are looking for an experienced and responsible professional for the position Contract Manufacturing Operations Manager (CMO Manager) to join the TPO division.

The main role of the CMO Manager is to guarantee that current pharmaceutical standards, legal regulations and approved registrations are implemented for the production and the controlling of Third Party manufactured products. 

• Supervise the entrusted products through the entire life cycle with regard to pharmaceutical quality.
• Take actions needed to guarantee the products quality and compliance: initiation, coordination, supervision and functional assessment of activities that are carried out by the relevant expert team.
• Support of qualified persons in tasks or meetings related to critical quality issues to provide a thorough and profound basis for decision-making.
• Implement and support projects within the department Quality TPO EU Generics to ensure compliance with internal standards. Close cooperation with qualified persons and Quality Officers as well as responsible company’s departments.
• Act as internal and external contact person for all issues concerning the pharmaceutical quality of third party manufactured products. 
• Coordinate and control of all Good Manufacturing Practices (GMP) relevant documents with regard to manufacturing process, quality control and quality assurance. 
• Interact with Total Productive Maintenance (TPM) and involved departments of the company’s group.
• Organize Quality Council Meetings, at defined intervals based on risk with CMOs as part of Business Review Meetings. 
• Collate key quality performance metrics agreed with CMOs & trends. 
• Collect status of Quality improvement actions (derived from audits, deviation & complaint investigations, risk assessments etc.). 
• Provide compliance status with QTA requirements.
• Prepare Senior Resource Team meetings. 
• Provide quality and performance KPIs, report about audit outcomes and other major quality events / concerns, etc.
• Ensure that all changes concerning Module 3 of a dossier are submitted to the authority in collaboration with Total Productive Maintenance (TPM) and RA.
• Analyze the pharmaceutical and quality relevant points of a deficiency letter sent by the authorities concerning renewals or variations. 
• Manage of the correction of the deficiencies. Creation of statements referring to the deficiencies with reference to the legal regulations and compliance to time limits.
• Conduct QA Due Diligence of Existing Contract Manufacturer:
- Deviations from the filed registration dossier, deficiencies of the GMP status or other open questions will be negotiated directly in direct contact with the supplier or manufacturer which may result in a Change Control 
- Procedures and necessary variations, an ad-hoc audit at the site of the manufacturer or in any other corrective action, based on which quality risk assessment is executed.
- Check and approve of Master Documents: CoA, Manufacturing Description, Manufacturing Instruction, Master Batch Record, Stability Schedules, Specifications etc. tol be authorized and forwarded back to the supplier in order to assure regulatory compliance on the supplier’s level
• Technical Visits/Audits:
- Preparation and realization of national and international technical visits in cooperation with other company’s departments. 
- Participation in audits and self-inspections.
- Follow up of Audits Corrective Action Preventive Action (CAPA) of Tier 1 and Tier 2 Supplier
• Review of Procedure Qualification records (PQRs)
• Approval of GMP documents without regulatory impact
• QC Documentation: CMO officer ensures the implementation of approved release and shelf life specifications and all corresponding methods by CMO and company’s laboratories. Ensuring the compliance of methods to GMP standards and the dossier. 

• Higher degree in Pharmaceutical/Natural/Engineering science 
• At least 4 years proven experience in the Pharmaceutica/Healthcare/Medical Devices/Food&Beverage/ Cosmetics industry
• First-hand experience in quality control, analytics, production and/or quality assurance
• Knowledge of manufacturing processes and test methods, regulatory requirements and guidelines 
• Good command of MS office, SAP and Track Wise
• High degree of self-initiative and keen sense of responsibility
• Excellent communication skills and very good level of English (written and spoken)
• Ability to work well as part of a team
• High degree of resilience

• Challenging and interesting position in a multinational company
• The opportunity to be part of a brand new structure in the company and set the standard 
• Competitive remuneration package
• Regular trainings

If you recognize yourself in this position, please send us your CV in English. Only shortlisted candidates will be approached.

All applications will be considered under the terms and conditions of confidentiality in accordance with the regulations of personal data protection. Wyser EOOD activities are based on a Recruitment license №1482 issued on 30.07.2012, valid until 30.07.2017
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