I&D Operational Excellence Specialist

Location

Mumbai | India

Job description

Job Description

Primary Job Function: Supports efficient and compliant execution of activities for Innovation & Development functions aligning to internal and external standards by taking responsibility for activities supporting the governance, quality operations and training for the department. Is the primary responsible for I&D Training and Governance activities.

Core Job Responsibilities:

Each individual assigned to this role will have 1-2 core responsibilities from the list below and may also serve as support/ backup for other activities listed. Those serving as u2018support/back up' would be expected to have the same level of competence, training, and ability as the lead.

Individual job descriptions will be individually tailored to separate the lead responsibility from the backup.

Training

• Support the implementation of training activities.
• Support implementation and maintenance of documentation and training systems within I&D
• Manage I&D training metrices.
• Maintain I&D user training matrix, modules 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 trainings in the system.
• Act as super user for selected systems.
• System set up of ISOtrain training records for (profile creation, curricula assignment).
• Support preparation of onboarding trainings for I&D functions.
• Support maintenance of worldwide staffing & contact lists when required.

Governance

• Support compliance and quality control activities for global I&D - tracking and conducting self-assessment activities in line with department self-assessment 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 assessment activities as required.

Supervisory/Management Responsibilities:

Direct Reports: 0

Indirect Reports: 0

Position Accountability/Scope:

• Responsible for supporting I&D training activities.
• Responsible for document quality control reviews & self-assessment activities
• Internal stakeholders, Operational Excellence, Medical Affairs, Clinical Development and Pharmacovigilance, Quality Assurance, Regulatory Affairs, Product Ideation & Development, 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

Minimum Experience/Training Required:

6-8 years of experience in Quality Management System and Training Management.

Job tags

Salary