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: Training and Compliance Specialist
Job Description:
Job Purpose:
Assist in developing, coordinating and implementing training programs for new and experienced IIS personnel in support of the IIS training strategy and also ensuring regulatory compliance and inspection / audit readiness across all IIS functional groups.
Major Activities:
1.Develop methods to establish training plans for local IIS departments (including use of Training Needs Analysis) and ensure training (including materials, methods, availability and assessment) are aligned with IIS training globally.
2.Establish global induction plan for new hires and work with manager to establish approach to ensure training records are correctly logged, maintained and stored
3.Develop and maintain relationship with Pharma Development Training and other Novartis training colleagues
4.Assist in the revision of cross functional documentation and training materials when a process is updated or developed.
5.Work with partner functions to create cross functional training materials
6.Performs regular quality reviews of IIS documentation across IIS functional areas as scheduled.
7.Provides interpretation of GCP regulations, guidelines, policies and procedures, and provides sound guidance to Novartis personnel, both verbal and written.
8.Provides regulatory /compliance guidance and interpretation and represents IIS C & Q in internal and external meetings.
9.Participates in process improvement initiatives and collects appropriate metrics and provides periodic scheduled reports on progress against process improvement objectives.
10.Co-ordinates and takes part as necessary, in the preparation, timely issue, review, updating and archiving of Standard Operating Procedures (SOPs), Novartis Internal Procedures (NIPs), and Working Procedures.
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Candidate Profile:
Education (minimum/desirable): Advanced degree preferred
Languages: Fluent English (oral and written)
Experience/Professional requirement:
1.At least 2 years previous experience in a training role
2.At least 3 years clinical/industry/health authority experience
3.Knowledge in computer technology and ability to support company use of electronic data systems including Electronic Data Capture
4.Knowledgeable in computer validation and Part 11 requirements
5.Knowledge of pharmacovigilance, clinical data management, or formal quality systems (e.g., CMM, Six Sigma, GAMP, RUP)
6.Expertise in GCP Regulations and well versed in Novartis SOPs
7.Ability to work effectively in a team environment, in multiple roles
8.Strong written and verbal communication skills, effective negotiation and leadership skills
9.Effective training and facilitation skills
10.Excellent organizational skills, with the ability to prioritize and work effectively in a constantly changing environment.
Additional Information:
Experience: min. 3 years
Location: Hyderabad
Education: B.Pharm, M.Pharm, M.Sc, B.Sc
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Medical
Division: Pharma
Job Type: Full Time
Employment Type: Permanent
Job ID: 83295BR
End Date: 24th July, 2011
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