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: Manager - R&D, QA & Compliance
Job Description:
The purpose of this role is to oversee and support the overall Quality 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.
• Support Global Product Development [GPD] team in Quality & Compliance, in the process of developing new launches as required by the intended market.
• Support & ensure Health Authority, Local regulatory & Novartis Quality systems are met with the GPD team.
• Lead and/or support Quality / Compliance initiatives to improve / harmonize NCH / NHPL Quality Sys-tems.
• Support R&D and Product Supply and provide assistance in project / technology / method transfer to commercial QA/QC.
• Implement, train & maintain Novartis GMP Quality Manual in R&D.
• Author, implement, train, periodic review of local and global SOPs.
• Review and approve CMC and non CMC related documents, including product specification, batch doc-umentation, test method, analytical validation report, method transfer, equipment qualification and cali-bration related documents, process validation protocol and reports and packaging documentation.
• Review & approve batch records, packaging records, CofAs, stability data, expiry dating etc.
• Support clinical supplies / pilot batches activities, including providing formal approval and release for clinical supplies / pilot batches and registration samples.
• Manage QA systems such as Change Control, Planned / Unplanned Deviation, Lab investigations, and CAPAs for R&D (Global Product Development).
• Perform cGMP audit of internal R&D facilities an operations as well as 3rd Party vendors and follow up with corrective action.
• Support Heath Authorities audits evaluate and follow up on the appropriateness and completeness of corrective action plans until closure.
• Participate in development of GMP training program, on job documentation training for R&D personnel and provide on-going GMP training to the R&D associates.
• Prepare Quality Agreement with new 3rd party / contract labs as required by the development team.
• Perform routine GMP rounds / visits to the laboratory & manufacturing area, ensure compliance, perform line clearance, review batch records online, perform AQL checks, in-process checks,
• Prepare technical reports.
• Provide monthly KPIs and status reports on projects and compliance initiatives to management.
• Perform other duties as required or necessary
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Major Accountabilities (Describe the 5-7 main results of the role to be achieved )
• Provide QA / Compliance assistance for product development, validation, transfers for new product launches.
• Implement and maintain Novartis GMP Quality Manual in R&D.
• Support and maintain Quality Systems & establish appropriate corrective and preventative actions towards continuous improvement.
• Provide support during internal and external (HA) audits and ensure all corrective actions are addressed as per designated timelines.
• Provide ongoing training to the R&D team & perform internal audits of the facility.
• Providing compliance guidelines and by interfacing with GMS to achieve timely transfer & launch.
Leadership: Innovation, Technical, Communication
• Leadership, communication, and organizational skills as demonstrated through projects and interaction with other departments
• Technical competence and impact on business
Key Performance Indicators (Indicate how performance for this role will be measured)
• Number of successful inspection outcomes [internal & external].
• Number of successful project launches and/or participation and support for new product launches.
• Quality deliverables described in performance management process (i.e. objectives, targets)
Candidate Profile:
Education :
Minimum Bachelor of Science in Pharmacy, Chemistry, or other Scientific Disciplines
Experience:
• At least 7 years experience in the pharmaceutical, consumer health, or medical device industry in the areas of Research & Development, manufacturing, quality and regulatory systems, process development.
• Experience in new facility setup & commissioning.
• Competent in training associates, innovate new systems, develop GMP culture for an organisation.
• 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.
Position may require 15 - 25% travel.
Additional Information:
Experience: Min. 7 Years
Location: Hyderabad
Education: B.Pharm, B.Sc - Chemistry, Life Sciences
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: QA, R&D
Division: Pharma
Job Type: Full Time
Employment Type: Permanent
Job ID: 87840BR
End Date: 6th Nov., 2011
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