Novartis Biochem / Microbiology Quality Assurance Job Opening
Novartis Biochem / Microbiology Quality Assurance Job Opening. BSc Biochemistry and Microbiology candidates apply online for a Quality Assurance Manager – ESO position that is available at Novartis. Novartis is hiring bsc candidates, as per the details below in their Research & Development area:
Job Title: Quality Assurance Manager – ESO
Job ID: 296263BR
Division: Novartis Technical Operations
Business Unit: NTO EXTERNAL SUPPLY
Employment Type: Full-time
Responsible for handling quality elements at external suppliers for Biopharmaceutical/ Pharmaceutical/ Devices and to ensure that the operational business is in compliance with cGMP, the Quality Assurance Agreement, regulatory requirements and the Novartis Pharma Quality Manual and is conducted according to the relevant SOPs.
Your key responsibilities:
Your responsibilities include, but not restricted to:
- Lead External Suppliers Qualification procedure. Acts as Single Point of Contact/ SPOC for all quality-related activities at the External Supplier. Ensure that all aspects of the handling, manufacturing and distribution of biopharmaceutical/ pharmaceutical products are in compliance with the Novartis Pharma Quality Manual, the effective Quality Agreement that they satisfy relevant cGMP regulatory requirements and are conducted according to local SOPs.
- Responsible for driving/ initiating External Supplier Quality Risk assessments to be carried out for all External Suppliers. Gaps are Quality Systems to be identified with an evaluation of the associated risks. Remediation plans are to be defined and execution is to be supervised to ensure that issues are suitably addressed.
- Provide the quality presence and in-put to Technical meetings with the External suppliers and establish good working relationships with clear communication and defined actions and objectives. Ensure that a valid QA agreement defined in accordance with the requirements of the Global template is in place which clearly defines cGMP roles and responsibilities between Novartis and the External Supplier, as well as Product details and requirements
- Request, review and process GMP documentation as defined by the Quality Agreement and Novartis SOPs. Handle the quality facets of the relationship according to the effective Quality Agreement. Perform the required periodic review and make recommendations for amendments to the agreement based on identified needs and issues.
- Responsible for coordinating and ensuring that Quality auditing of External suppliers is carried out according to the Novartis Quality Manual – maintain an annual auditing program, participate in and/or lead audits, handle action plans and follow up on agreed upon CAPAs. Ensure site readiness for regulatory inspections at External suppliers where appropriate.
- Handles 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.
What you’ll bring to the role:
- Bachelor or higher degree; preferred in Biochemistry, Microbiology or another related science Fluent in speaking/ writing in English
- 5-10 years experience in the pharmaceutical industry, with direct experience with pharmaceutical/Biopharmaceutical/API products. Experience in QA Operations, production, QC and/or other relevant operational areas, however, should include minimally 5 years in QA, and 3 years of management and or project management experience.
- Thorough knowledge of cGMP requirements. Solid understanding of regulatory requirements for commercial products.
- Consistent record with FDA, EMEA and other Health Authorities.
- Solid understanding of risk assessment and risk management fundamentals/tools. Strong Technical understanding of pharmaceutical processes. Group and consensus builder, with definitive and authoritative decision-making capability.
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