A global healthcare leader, Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes them one of the most rewarding employers in their field.
Post : Senior Executive GMP QA
Job Description
Monitor quality governance and compliance in the Country organization in all GxP related areas (Supply chain, C&F Ware house, Market Compliant, Clinical trials 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. 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 perform the respective activities are in compliance with Novartis Standards. Ensure Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GPvP) oversight and quality & compliance of Development and Medical Affairs (MA) projects, products and programs (Phase I through Phase IV). Review and Approve Investigation Medicinal Product (IMP) release activity with ICRO / Medical / Clinical QA. Participate in resolving 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 managed according to the Quality Assurance Agreement and/or Novartis SOPs from receipt, through to the implementation and closure. Responsible for preparing Quality trends and driving Continuous improvement for processes and product quality performance. Provide the quality presence and in-p.
Candidate Profile
B.Sc., B.Pharm Post graduate Diploma added advantage Local language, English & Hindi fluent in speaking / writing 2-3 years in QA / QC.
Additional Information:
Experience: 2-3 years
Industry Type: Pharma/ Healthcare/ Clinical research
Functional Area: QA
Job ID: 223803BR
Last Date: 21st October, 2017
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