Recruitment for M.Pharm. M.Sc as Head in Quality System at Novartis

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 : Head - Quality System

Job Description
1) Site Readiness for Health Authority inspections
2) Lead the site inspection readiness team.
3) Host for inspections.
4) Prepare and drive site quality sustainability plan based on last 3 years of HA inspections and internal quality improvement plans.
5) Enhancement of site system and compliance by leading through proactive compliance initiatives i.e. structured site quality enhancement plan, self-inspections, CAPA effectiveness etc.
6) Strong collaboration with cross functional team for developing quality commitment and mindset.
7) Establish mechanism for external intelligence and learning from other Novartis sites and Pharma industry to enhance site compliance 8) SME (Subject matter Expert) alignment and training.
9) Form dedicated task force as per priorities and needs.
10) Senior leadership alignment at site.
11) Deputize site quality head during his absence or during critical compliance activities time to time.
12) Culture change - liaise with Continuous Improvement Department.
13) Inspection readiness trainings.
14) SME rehearsals and spot reviews.
15) Front Room & Back room readiness.
16) Action tracking with PMO (Project Management Officer), reviews and completion.
17) Participate in unannounced inspections to follow-up on HA inspection observations and CAPA sustainability.
18) Leadership for site self-inspections, act as lead / support inspector for key areas of self-inspections
19) Third party engagement for quality enhancement projects

Candidate Profile
M.Sc / M.Tech / M Pharm with 15-20 years of experience

Additional Information:
Experience: 15-20 years
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Quality
Job ID: 214218BR
End Date: 28^th October, 2017