Job Description

JOB DESCRIPTION:

The I&D Operational Excellence Specialist supports the efficient and compliant execution of I&D activities to internal and external standards by supporting I&D quality system, training and governance activities.

Core Job Responsibilities

• Governance

• Support compliance and quality control activities for global I&D - tracking and conducting self-inspection activities in line with department self-inspection plan
• Maintain department 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
• 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 liase with DARIUS 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 system
• Acts 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

Supervisory /Management Responsibilities

Direct Reports: NA

Indirect Reports: NA

Position Accountability / Scope:

• Responsible for document quality control reviews & self-inspection activities
• Responsible for supporting I&D training activities
• Internal stakeholders Medical Office (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

• Bachelor of Science in a field related to life sciences or equivalent by experience

Experience:

• At least 3-years experience in pharmaceutical industry
• Understanding of GxP principles
• Experience with working in a Global fast paced environment
• Attention to detail, organized, capable of multi-tasking, capable of working independently
• Proficient in MS office applications especially Excel and Word
• Experience of quality control and/or training preferable
• Fluent in English

The salary for this role is between: N/A

JOB FAMILY: Medical & Scientific Affairs

DIVISION: EPD Established Pharma

LOCATION: India
Mumbai : BKC Building

ADDITIONAL LOCATIONS:

WORK SHIFT: Standard

TRAVEL: Yes, 25 % of the Time

MEDICAL SURVEILLANCE: Not Applicable

SIGNIFICANT WORK ACTIVITIES: Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day)

Abbott