I&D Operational Excellence Specialist

JOB DESCRIPTION:

Core Job Responsibilities:

• Governance

• Support compliance and quality control activities for global Innovation &Development (I&D) - tracking and conducting self-inspection activities in line with department self-inspection plan
• Maintain department training related quality and compliance metrics
• Ensure I&D records comply with global guidelines and applicable regulations.
• Perform quality control review of documents (e.g. check content consistency, pagination, spelling grammar, referencing, formatting etc.)
• Support internal and external inspection activities as required.
• Support regulatory Non-Conformances and relevant activities.

• Training

• Support the implementation of training activities.
• Support implementation and maintenance of documentation and training systems I&D
• Manage I&D training metrices.
• Maintain I&D user training matrix and curricula.
• Prepare I&D quality system documents and liaise with Quality group to prepare document package for new/ revised quality documents.
• Content upload/ course creation in training system (ISOtrain) for I&D
• Assign training in the learning management system.
• Act as super user for selected systems.
• System set up of ISOtrain training records for (profile creation, curricula assignment)
• Support preparation of onboarding packages for I&D

Position Accountability/Scope:

• Responsible for document quality control reviews & self-inspection activities
• Responsible for supporting I&D training activities
• Internal stakeholders, Operational Excellence, Medical Affairs, Clinical Development and Pharmacovigilance, Quality Assurance, Regulatory Affairs, Office of Ethics and Compliance, global, regional and local
• External stakeholders business partners (contractors, consultants, vendors)

Minimum Education:

• Post Graduate Diploma in Quality Assurance for Food and Pharmaceutical Industry preferred
• Bachelors/ master s in science

Minimum Experience/Training Required:

7+ years of experience In Quality Management System and Training Management.

The base pay for this position is

N/A

In specific locations, the pay range may vary from the range posted.

JOB FAMILY: Medical & Scientific Affairs

DIVISION: EPD Established Pharma

LOCATION: India > Mumbai : BKC Building

ADDITIONAL LOCATIONS:

WORK SHIFT: Standard

TRAVEL: Not specified

MEDICAL SURVEILLANCE: Yes

SIGNIFICANT WORK ACTIVITIES: Keyboard use (greater or equal to 50% of the workday)