You are here
- Quality Manager
- Qualified Person
About Our Client
For one of the biggest international organisations in the pharmaceutical industry we are looking for a Quality Manager.
- Ensure that all aspects of the handling, manufacturing and distribution of pharmaceutical products in the country comply with the requirements of the Novartis Quality Manual and Policies and meet all relevant cGMP regulatory and legislative requirements.
- Ensure that a local Quality System and Standard Operating Procedures are in place for all GMP/GDP related activities and that compliance with cGMP/GDP regulations is maintained through training and internal audits.
- Maintain current knowledge of local and international regulatory and legislative requirements and trends to ensure that technical support on all quality related matters is provided to the country.
- Establish a good working relationship with the Supply Chain Management (SCM), ICRO, Trial Logistics and DRA departments.
- Ensure that coordinated contact is maintained with the Regulatory Authorities, the local partners (suppliers, third parties, licensees, and distributors) and Global Quality Assurance.
- Ensure that all drug products (commercial products, trial medication, named patient medication, medical devices) are released to the market in accordance with the registered specifications and with local/international regulations.
- Provide strategic GMP/GDP input to prevent or limit product stock-out.
- Take decision on product recalls (in consultation with the QA Head).
- Ensure that an effective Change Control process is in place.
- Ensure timely approval of Artwork/packaging material (e.g. labels, folding boxes, leaflets) for drug products.
- Audit, supervise and co-ordinate third party activities and ensure that third party manufacture, (re-)packaging, (re-)labelling, storage and/or distribution of Novartis products is in compliance with Novartis Standards.
- Ensure CPO readiness for all GMP/GDP regulatory inspections and internal or external audits.
- Manage external inspections, complaints, temperature excursions, deviations, recalls, product defects, counterfeits and product tampering according to the Novartis Corporate Quality Manual and local written procedures. Support / participate in NEM cases as required.
- Ensure conduct of adequate training at the CPO for all GMP and GDP related activities by defining, planning and supporting training activities.
The Successful Applicant
- University Degree in Life Sciences or related fields
- Must be eligible to act as Qualified Person under local legislative requirements
- Dutch and English fluent in speaking and writing
- Min. 5 years experience in the pharmaceutical industry in a relevant field such as quality assurance, quality control, registration, production or a directly related area.
What's on Offer
- Excellent primary and secondary benefits
- great growing opportunities