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Novartis Pharmaceuticals Corporation
Asc Dir Quality Assurance - CMO (Emeryville, Calif) -- 56716BR
Location: Emeryville,
California
94608
Posted on:
9/14/2009 9:24:29 AM
Postion type:
Full time
Job Code:
1683528HHL
Required Education:
Bachelor's Degree
Salary:
DESCRIPTION
-Responsible for managing quality aspects at Third Party Contract Manufacturers for Biopharmaceuticals and to ensure that the operational business is in compliance with cGMP, regulatory requirements and the Novartis Pharma Quality Manual and conducted according to the relevant SOPs.
Major accountabilities include:
With third party contract manufacturers:
-Ensure that all aspects of the handling, manufacturing and distribution of biopharmaceutical 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.
-Provide the quality presence and in-put to Technical meetings with the Third Parties and establish good working relationships with clear communication and defined actions and goals.
-Ensure that a valid QA agreement is in place which clearly defines cGMP-relevant activities at the Third Party as well as Product details.
-Request, review and process GMP documentation as defined by the Quality Agreement and Novartis SOPs. Perform activities and assume responsibilities for the management of 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.
-Ensure that Quality auditing of Third Parties is carried out according to the Novartis Quality Manual - maintain an annual auditing program, participate in and/or lead audits, manage action plans and follow up on agreed upon CAPAs. Ensure site readiness for regulatory inspections at Third Parties where appropriate.
-Manage all 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.
-Support / participate in Novartis Emergency Management cases as required.
-Ensure that Change requests, either from the Third Party or from Novartis, are managed according to the Quality Agreement and Novartis SOPs from receipt, through to the implementation and closure.
Within the organization
-Implement and maintain a local Quality System and Standard Operating Procedures defining all the processes for managing of Third Parties.
-Ensure that the Head of QA BPO Third Party Management & Capacity Planning is kept informed of all critical and major issues which may have an adverse affect on the quality of the product at a Third Party
-Together with the Key Account Manager provide direction, formulate strategies and make decisions which ensure the efficient operation of the Third Party business as a whole - Participation in the Business review of Third Parties.
-Participate in the Reporting on QA Third Party activities - this is to include Risk Assessment, reporting and managing of defined KPI’s
-Ensure that coordinated contact is maintained with other functions within Novartis also dealing with Third Parties namely Purchasing, Legal, Supply Chain, Regulatory CMC, Drug Regulatory Affairs, Group Quality Operations (GQO), etc
Personal development
-Maintain current knowledge of local and international regulatory and legislative requirements and trends
REQUIREMENTS:
-Bachelor or higher in Biochemistry, Chemistry, Microbiology or another related science
-Fluent in speaking / writing in English
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