Job Description
80+ major submissions planned to 2022 major submissions. This is your chance to help reimagine medicine in 2020 and beyond with Novartis.
The QA Associate (m/f/d) ensures compliance of the country organization with cGMP/GDP, legal and regulatory requirements and the Novartis Quality Manual and Policies.
Your responsibilities:
Your responsibilities include, but are not limited to:
• 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.
• Report monthly Key Quality Indicators (KQIs) related to GMP/GDP activities to Country Organisation QA and monitor them and assure that gaps are addressed appropriately in order to mitigate risk.
• Ensure that co-ordinated 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 and Investigational Medicinal Products (IMP) are released to the market in accordance with the registered specifications and with local/international regulations. Ensure that an effective Change Control process is in place.
• Ensure quality oversight of third party and coordinate all required activities to guarantee that third party manufacture, (re-)packaging, (re-)labelling, storage and/or distribution of Novartis products is in compliance with Novartis Standards.
• Ensure readiness for all GMP/GDP regulatory inspections.
• Manage external inspections, complaints, deviations, recalls, counterfeits and product tampering according to the Novartis Corporate Quality Manual and local written procedures. Support / participate in NEM cases as required and ensure relevant CAPAs have been completed/closed.
• Degree in Life Sciences or related fields.
• Preferably 2-3 years experience in the pharmaceutical industry in a relevant field such as quality assurance, quality control, registration, production, distribution or a directly related area.
• Fluent English in speaking and writing.
• Flexibility to work in a fast paced, quickly changing work environment.
• Ability to operate in a global matrix environment.
