Manager Country Quality

Job Description

Monitor quality governance and compliance in the Country organization in all GxP related areas (Supply chain, C&F Ware house, Market Compliant, etc) to ensure that all aspects of the operational business comply with cGxP, legal and regulatory requirements and the Novartis Pharma Corporate Quality Manual and Policies. Prevent significant quality issues or regulatory non-compliance which could lead to product stock-out or withdrawal, product approval delays or which would negatively impact the financial performance of the company as well as the reputation.YOUR RESPONSIBILITIES:Your responsibilities include, but are not limited to:- Ensure implementation, maintenance and upgrading of the local Quality System and Standard Operating Procedures in order to drive compliance of all cGXP and Pharmacovigilance related processes and tasks with local/International regulatory requirements and the Novartis Quality Manual.- Actively involved in ensuring quality governance and quality planning in the Country organization through the establishment and implementation of the annual Quality Plan, appropriate Key Quality Indicators, and Quality Risk Assessments. Ensure that a local Quality System and Standard Operating Procedures are in place for all GxP related activities and that compliance with cGMP is maintained through training and internal audits. - Ensure that all drug products are released in accordance with the registered specifications and are released to the market in accordance with local regulations and ensure that a respective Change Control procedure is in place. (Batch Release). - Ensure that all aspects of the handling and distribution of pharmaceutical products at Novartis India Limited through Central Warehouse & C & F s comply with the requirements of the Novartis Pharma Quality Manual and Policies and meet all relevant cGMP, regulatory and legislative requirements. - Visit, supervise and co-ordinate CPO Vendors(C&Fs, Stickering site etc) activities and ensure that vendor performs the respective activities are in compliance with Novartis Standards. Lead all Critical Quality Issues (deviations, complaints, recalls, counterfeits and product tampering, stability failures, etc) according to the Quality Assurance Agreement and the Novartis Pharma Quality Manual. Ensure investigations are correctly executed. Ensure they are updated in AQWA (Adaptable Quality Workflow Application). - Ensure that Change requests, either from the External Supplier/Vendor or from Novartis CPO, are handled according to the Quality Assurance Agreement and/or Novartis SOPs from receipt, through to the implementation and closure. Responsible for assessing Quality trends and driving Continuous improvement for processes and product quality performance. - Provide the quality presence and in-put to Compliance / Technical meetings with the CPO Vendors and establish good working relationships with clear communication and defined actions and goals. In addition, provide support to internal functions (BD&L, CRO and other functions) by evaluation and decision of new products as per Novartis Pharma Quality Manual and standards. Perform the required periodic review and make recommendations for amendments to the evaluation based on identified needs and issues. - Ensure that co-ordinated contact is maintained with the Regulatory Authorities, the local partners (suppliers, third parties, licensees, and distributors). Participate in the Reporting to Local and Regional Management on QA activities - this is to include Risk Assessment, Monthly reporting and KPI s. Establish system to provide inputs DRA for updation of product information in DRAGON. - Ensure that coordinated contact is maintained with other functions within Novartis namely Purchasing, Legal, Supply Chain, Drug Regulatory Affairs, Marketing, KAM Team etc. Participate in projects as defined and ensure that all aspects are implemented and followed up. - Bring up all potentially quality issues as per the Novartis escalation policy, and initiate all actions as defined. Maintain current knowledge of local and international regulatory and legislative requirements and trends to ensure that technical support on all quality related matters is provided to the internal and external customers.Minimum requirements WHAT YOU LL BRING TO THE ROLE: EDUCATION :- Bachelor or higher in Biochemistry, Chemistry or another related science. - Proven experience of 9+ yrs in the pharmaceutical industry, with direct experience in QA / QC.- Good Knowledge of cGMP and regulatory compliance of all relevant operations like C and F cold chain etc. - Interacting with people from interface functions in the local organisation. Support for resolving GMP and GxP related issues.LANGUAGES: Local language, English & Hindi proficient in speaking / writing,

Keyskills :
certified tips trainerdrug regulatory affairsstandard operating procedurescold chainsupply chainchange controlquality systemrisk assessmentproduct quality