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| Job Location | Hyderabad |
| Education | Not Mentioned |
| Salary | Not Disclosed |
| Industry | Medical / Healthcare |
| Functional Area | General / Other Software |
| EmploymentType | Full-time |
Responsible for managing quality aspects at external suppliers for Biopharmaceuticals / 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 responsibilities: Lead External Suppliers Qualification process. 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 meet 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 monitored 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 goals.
Ensure that a valid QA agreement defined in line 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.
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 issues.
Minimum requirements
Desirable Requirements: Bachelor or higher degree; preferred in Biochemistry, Chemistry, Microbiology or another 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 other relevant operational areas, but must include 3 minimally 5 years in QA, and 3 years of management and or project management experience.
,Keyskills :
continuous improvement facilitationquality systems supplier qualityquality assurance project managementtechnical operations regul