PART-TIME Quality Manager & Qualified Person GMP
Novartis
- Praha
- Dočasný pracovní poměr
- Částečný úvazek
Location: Novartis, Prague, Czech Republic #LI-Hybrid
PART-TIME roleAbout the Role:
- Assurance that the product quality conforms with specifications and that production activity is compliant with Novartis quality policy and GxP requirements.
- Ensure that relevant documentation is up-to-date and archived correctly. Ensure “state of the art” GxP know-how and future trends in the field of GxP
- Perform role of local Qualified Person listed on Novartis GMP license namely in scope of performance of batch confirmation for all imported batches in compliance with requirements arising from the Act No. 378/2007 of Coll., §66, as amended and oversighting batch certification by EU QP after importation to the Country
- Ensure that all aspects of the handling, manufacturing and distribution of biopharmaceutical / pharmaceutical products are in compliance with the Novartis Quality Manual, the effective Quality Agreement that they meet relevant GxP regulatory requirements and are conducted according to local SOPs.
- Review and check the batch documentation for correctness, completeness and safely archive the original documents for the prescribed period and plan, conduct and monitor self-Inspection schemes for all sections. Monitor actions and corrections accordingly.
- Conduct GxP monitoring on all sections, conduct QA investigation for noncompliance, follow up the corrective actions. Archive relative documentations and manage/Approve critical quality issues (deviations, complaints, recalls, counterfeits and product tampering, stability failures, etc.) according to the Quality Agreement and the Novartis Quality Manual. Ensure investigations are correctly executed. Ensure all required actions are taken appropriately and in a timely fashion.
- Escalate any issues or instances of instability per the Novartis escalation policy, and initiate any market action that is required. Decide escalation to Senior Management Level and lead Global Quality Assessments and manage filing accordingly as well as ensure that Change requests, are managed according to the Novartis SOPs from receipt, through to the implementation and closure.
- Responsible for assessing quality trends and driving continuous improvement for processes and product quality performance and maintain access to regulatory and Health authorities in respect to up-dated GxP Provide latest know how in the field of GxP and other quality related fields. Identify repetitive activities and regulatory areas for which SOPs are required. Initiate the introduction of SOPs.
- Plan, initiate and monitor basic GxP-training for all employees in regular intervals. Be responsible for annually training program and implementation.
- Establish and maintain cross-functional contacts with peer organization and authorities and, follow-up quality related developments in the field of Pharmaceutical products.
- Support launches of product in close collaboration with Business and/ or development organization.
- Ensure that all drug products are released to the market in accordance with local/international regulations.
- Ensure that coordinated contact is maintained with all parties (the Regulatory Authorities, the local partners and stakeholders and Global QA.)
- Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt.
- The Qualified Person of a manufacturer of medicinal products for human use (QP GMP) shall ensure that the requirements arising from the Act No. 378 / 2007 of Coll., § 66, as amended, are fulfilled namely in scope of importation as per Novartis set up.
- Professional services of Qualified Person GMP are performed in the premises of Novartis s.r.o., Gemini, budova B, Na Pankráci 1724/129, 140 00 Praha 4 and Novartis warehousing facility at Movianto Česká republika s.r.o., Podolí 78e, 664 03 Podolí.Role RequirementsEssential Requirements:1. Minimum acceptable degree: according to requirements of the Act on Pharmaceuticals No. 378/2007 of Coll., §65, i.e. regularly completed academic study which provides academic education including at least 4 years of theoretical and practical education in one of the following fields of education:
- pharmacy - field of study: pharmacy,
- general medicine, dentistry, or stomatology,
- veterinary medicine or veterinary hygiene and ecology,
- chemistry, or
- biology.
- qualitative analyses of medicinal products,
- quantitative analyses of medicinal products and
- testing and control required for quality assurance of medicinal products.
- Experience in pharmaceutical company (e.g. QA, RA, SCM, R&D) on top of above mentioned minimum two-years practice at one or more manufacturers of medicinal products is an advantage.
- Fluent in local and English language
- Collaborating across boundaries Functional Breadth; Operations Management and Execution
- Being resilient Operational Excellence; Project Excellence; Flexibility
- Product Release Quality Assurance Quality Change; Control Quality Management; Regulations & Guidelines; Risk Management