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Opening for Senior Manager QA & GMP Compliance in Novartis

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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: Sr Manager QA & GMP Compliance

Job Description:
The purpose of this role is to manage overall GMP and Compliance activities during the product development life cycle processes and to ensure related practices adhere to market(s) Health Authority regulatory requirements as well as the Novartis Corporate GMP Quality Manuals. In addition, to ensure R&D activities are in compliance with regulations.
•Manage and lead, as appropriate, the Quality / Compliance activities for all assigned new product launches.
•Manage and lead Quality / Compliance initiatives to continuously improve NCH Quality Systems.
•Act as liaison between R&D and Product Supply and provide assistance in project transfer to commercial QA/QC.
•Implement and maintain Novartis GMP Quality Manual in R&D.
•Author and implement local and global SOPs.
•Maintain GMP status of Pilot lab for manufacturing clinical trial batches
•Review and approve CMC and non CMC related documents, including product specification, batch documentation, test method, analytical validation report, method transfer, equipment qualification and calibration related documents, process validation protocol and reports and packaging documentation.
•Support clinical supplies activities, including providing formal approval and release for clinical supplies and registration samples.
•Manage Change Control, Unplanned Deviation and CAPAs for R&D (Product Development and Analytical Development.
•Perform due diligence audits and provide QA / Compliance expertise for business development initiatives as required.
•Perform cGMP audit of internal R&D facilities an operations as well as 3rd Party vendors and follow up with corrective action.
•Manage Heath Authorities audits including corrective actions & preventive actions
•Participate in development of GMP training program for R&D personnel and provide on-going GMP training to the R&D associates. Ensure training of R&D personnel in global GMP QA procedures.
•Provide QA / Compliance support for manufacturing and packaging activities at 3rd party operations.
•Serve as a member of the Global Research Stability Evaluation Committee to ensure the practices adhere to current Novartis guidelines.
•Prepare Quality Agreement new products to be launched.
•Provide QA / Compliance support as a member of the project transfer team from internal and external R&D / development sites to manufacturing facilities.
•Contribute to selection initiatives for material suppliers by providing quality due diligence assessments.
•Prepare technical reports.
•Provide monthly KPIs and status reports on projects and compliance initiatives to management.
•Perform other duties as required or necessary. Provide QA / Compliance leadership for new product launches. Evaluate and implement Quality guidelines within R&D organization to ensure practices adhere to current regulations. Implement and maintain Novartis GMP Quality Manual in R&D Support and lead Quality investigation from compliance perspective in order to establish appropriate corrective and preventative actions. Provide leadership support during internal and external (HA) audits and ensure all corrective actions are addressed as per designated timelines. Support R&D team by providing compliance guidelines and by interfacing with GMS to achieve timely transfer. Leadership, communication, and organizational skills as demonstrated through projects and interaction with other departments Technical competence and impact on business

Candidate Profile:
Minimum Bachelor of Science in Pharmacy, Chemistry, or other Scientific Disciplines English
•At least 8 years of experience in the pharmaceutical, consumer health, or medical device industry in the areas of manufacturing, quality and regulatory systems, process development.
•QA and cGMP experience in Pharmaceutical, GMP and regulatory (GxPs) requirements including auditing and inspection against regulatory / quality standards.
•Demonstrated experience in managing multiple projects and deadlines.
•Good communication, planning, and organization skills.
•In depth understanding of pharmaceutical manufacturing, regulatory constraints, validation and product development.
•Excellent analytical, organizational, and problem solving skills.
•Good knowledge of computer systems, i.e. Microsoft, Word, Excel & PowerPoint.
•Demonstrated understanding best pharmaceutical industry practices, cGMPs, and Quality Assurance and Regulatory.
•Team oriented individual with personal commitment to human relations, integrity, giving and receiving constructive feedback, adaptability, diversity and communication. Must be adaptable to a diversified working environment. Experience in third party contract operations is preferred.
•Position may require 25 - 35% travel.

Additional Information:
Experience: Min. 8 Years
Location:
Hyderabad
Education: B.Pharm, B.Sc

Industry Type: Pharma/ Biotech/Clinical Research
Functional Area:
QA
Division: Pharma
Job Type: Full Time
Employment Type: Permanent
Job ID:
130354BR
End Date: 24th Nov., 2013

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