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Post: Manager - QA & Compliance
Job Description:
Manage and coordinate Quality oversight in India to assure OTC products manufactured at local Third Party Organization (TPO) manufacturers and handled at distributors are done in compliance with Novartis standards and GMP. Lead the development, maintenance and improvement of quality systems to support OTC business continuity in the Operating Unit. Evaluate the level of GMP compliance for products manufactured, packaged, tested and released by 3rd Party suppliers in the Operating Unit through key performance indicators (KPI) and quality performance indicators (QPI). Implement quality action plans at 3rd Party Suppliers to minimize risks. The incumbent acts as the single point of contact between the third party and the Quality organization in Novartis OTC in the Operating Unit and assure the quality of OTC products is maintained from new product launches, through commercialization and distribution in these markets.
Major Accountabilities
Building the Quality Systems
• Ensure implementation of Novartis Quality System within the assigned Operating Unit such as Quality Manual, Global Standard Operating Procedures, and Implementation Guidelines so that it is recognised by Novartis and by regulatory authorities as a quality committed company.
• Identify, develop and implement additional quality systems documents and local procedures needed for OTC India to close gaps when necessary.
• Ensure appropriate QA management is in place to cover 3rd Party activities in the Operating Unit impacted by GMP including manufacturing and distribution sites. : ensure 3rd Party manufacturers used within the assigned Operating Unit comply with GMP requirements, have appropriate QA agreements in place, and are audited in due time and appropriate recommendations made.
Business continuity / Management of quality risks at third party
• Manage the release function and hold the release authority in SAP for OTC product released in India. Supervise and delegate when appropriate to QA associates in support to batch release activities within the Operating Unit.
• Approve stability and validation requirements/protocols/reports, QA investigations, and annual product reviews, procedures and GMP control documents.
• Manage the Change Control program to ensure that changes affecting marketed product are documented, evaluated and implemented per Novartis requirements.
• Manage the Deviation Management system including the CAPA program to investigate incidents and identify adequate corrective measures to prevent their recurrence.
• Manage the documentation management system (GEMA) to ensure procedures are up to date and accurate for their intended use.
• Develop, implement and maintain Raw Material, Packaging Components, Labeling and Finished Products specifications.
• Manage the Annual Product Review in accordance with the Novartis requirements.
Compliance and Quality Culture
• Manage the periodic reviews of quality and/or compliance performance of OTC products distributed within the Indian market.
• Stimulate action taking at appropriate level to correct quality weaknesses, avoid failures and repetition of quality problems. Monitor corrective actions.
• Drive specific inquiries deemed necessary to assess exposure or compliance of Novartis OTC products within the assigned Operating Unit.
• Define, raise and measure key and quality performance indicators for 3rd Party within the assigned Operating Unit.
• Provide guidance to 3rd party manufacturing sites and relevant OTC country organisations to minimize the compliance risk for Novartis products and to avoid or minimise duration of stock-out situations.
• Lead training initiatives, support training and team development, and participate in high performing teams to support business growth
• Evaluate periodically the quality systems at the contract manufacturing sites and warehouses in line with Novartis third party assessment standards’ to ensure that the any compliance gaps have been identified and adequate remediation plan is in place
Candidate Profile:
Education
Qualifications in Chemistry, Pharmacy, Biology, or related Science or discipline.
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Experience
At least 12-15 years relevant experience in a regulated Pharmaceutical industry including Quality Assurance, Quality Control, R&D and/or Drug Regulatory Affairs.
Strong business knowledge in Quality Systems with strong technical knowledge of GMP requirements associated with pharmaceutical production (facilities, equipment, production processes, and laboratory controls)
Experience in a pharmaceutical manufacturing environment with demonstrated ability to interpret and implement international pharmaceutical GMP requirements. Possess a strong attention to details with record of driving quality performance with a quality-focused attitude.
Experience in managing 3rd party facilities.
An established leader who can demonstrate his/her ability to implement Quality Systems while supporting the execution of key day-to-day QA processes in support to a commercial operations.
Excellent communication and presentation skills. Able to independently and professionally represent the company with third party organizations and commercial partners
Independent and flexible to re-organise own use of time to face emergencies in the organisation.
Shows insight and good judgement in assessing complex situations or uncertain alternatives, including the risks of each. Considers impact of decisions on other part of the organization before making them
Ability to motivate and energise colleagues in OU for quality improvement initiatives through good interpersonal and leadership skills.
Experience in working in an international and multidisciplinary environment.
Additional Information:
Experience: Minimum 12-15 years
Location: Thane
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: QA
Division: Pharma
Job Type: Full Time
Employment Type: Permanent
Job ID: 119818BR, 131003BR
End Date: 30th Nov., 2013
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Job ID: 119818BR
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