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Specialist - Quality Operations
ConfidentialHyderabad / Secunderabad, Telangana30+ days ago
Job descriptionDevelops and maintains a Quality Assurance Agreement in cooperation with the external partners. Responsible for the initial qualification and onboarding of contract manufacturers as well as for performing regular quality risk assessments. Ensures that all aspects of manufacturing, testing, release and distribution of drug substance / drug product / intermediate product / material are in compliance with applicable ADACAP and Novartis standards, the effective Quality Assurance Agreement, relevant guidelines and the Quality Management System of the external partners. Manages and oversees contract manufacturer s activities related to quality processes such as deviations, complaints, recalls, counterfeits, product tampering, stability failures, etc. according to the Quality Assurance Agreement and the Novartis Quality Manual. Ensures investigations are appropriately executed within agreed timelines, including documentation and effective measures to prevent recurrence. Support the Novartis audit of contract manufacturers and act as QARP and or FURP as required. Ensures that change requests, either from contract manufacturer or from ADACAP, are managed according to the Quality Agreement and ADACAP change control procedures from receipt, through to the implementation and closure. Reviews third party documents from a quality point of view (i.e. product test methods, specifications, and protocols / reports for activities such as stability, analytical method transfer, manufacturing process transfer, product comparability, process characterization, process validation, etc.). Performs, coordinates or archives GMP documentation as defined by the Quality Agreement and ADACAP SOPs. Responsible for compiling product quality reviews in cooperation with external partners. Initiates and drives quality improvement projects as required. Supports the quality function on general topics as assigned. Writes and maintains general concept descriptions of the assigned topics and presents the assigned topic in audit situations. Develops related procedures or provides input as needed. Escalates significant quality incidents and supply risks as per ADACAP and Novartis escalation policies to management. Responsible for reporting and trending of defined key performance indicators per assigned contract manufacturers. Implement and maintain a local Quality System and Standard Operating Procedures defining all the processes for managing of External suppliers. At least 6 years of experience in pharmaceutical quality assurance, quality control or manufacturing At least 3 years of experience in a Quality Assurance function Thorough knowledge of cGMP requirements and their practical application in routine biological manufacturing Proven track record of maintaining quality oversight on external partners Experience with biological manufacturing would be an additional asset Good communication skills Team and consensus builder, with definitive and authoritative decision making ability.
Skills Required
Audit Support, Quality Assurance
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Quality Specialist • Hyderabad / Secunderabad, Telangana