Novartis Quality Assurance Job – Biochem & Microbiology Apply
Biochemistry / Microbiology candidates apply online for a Sr. Quality Assurance Manager position that is available at Novartis. Sr. Quality Assurance Manager jobs for biochem & microbiology candidates. Check out all of the details regarding the QA vacancy given below:
Job Title: Sr. Quality Assurance Manager
Job ID: 280768BR
Location: Hyderabad, AP
Division: Novartis Technical Operations
Business Unit: NTO QUALITY
Employment Type: Regular
Responsible for managing quality aspects at external suppliers for Biopharmaceuticals/ Pharmaceutical/ Devices and to ensure that the operational business remains in compliance with cGMP, the High-quality Assurance Agreement, regulatory requirements and the Novartis Pharma Quality Manual and is conducted according to the pertinent SOPs.
- Lead External Suppliers Qualification process.
- Function 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 meet appropriate cGMP regulatory needs 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 monitored to make sure that issues are accordingly resolved 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.
- Make certain that a valid QA agreement specified according to the requirements of the Global template is in place which plainly defines cGMP duties and obligations in between Novartis and the External Supplier, as well as Product details and needs Demand, testimonial and procedure GMP documents as specified by the High quality Agreement and Novartis SOPs. Manage the quality aspects of the relationship in accordance with the effective Quality Agreement.
- Perform the required periodic review and make recommendations for amendments to the agreement based on identified needs and problems.
Bachelor or higher degree; chosen in Biochemistry, Chemistry, Microbiology or one more related science English fluency 5-10 years experience in the pharmaceutical industry, with direct experience with Pharmaceutical/Biopharmaceutical/API products. Experience in QA Operations, production, QC and/or various other pertinent operational locations, yet must consist of 3 minimally 5 years in QA, and 3 years of management and or project management experience.
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