Title: Cluster Support

JOB DESCRIPTION- Cluster Support

Job Summary:

Provide guidance and support to Site Quality on closing non-compliances, lead enhancement projects related to product quality, compliance, and simplification, set milestones for effective execution of project actions, maintain substantial compliance at all sites by harmonizing and implementing Quality Systems and procedures in alignment with Global Policies and Standards, act as a champion for building a "Culture of Quality" across the organization, and assure that all sites are ready for all Regulatory and Customer inspections at all times.

Responsibilities Assigned:

• Act as COE to provide guidance to Sites to ensure achievement of target for Quality & Compliance as per Management’s expectation.

• Review site investigation reports for major/critical non-conformances and share comments with site for improvement of root cause analysis.

• Support site for audit readiness by performing gap assessment through site visits and/or document review remotely for compliance enhancement and to track the action plan for remediation of gaps identified during Visit/Review.

• Support Quality Cluster Head in ensuring Quality or regulatory non-compliance issues don’t happen, which could lead to product stock-out or withdrawal, product approval delays or which would negatively impact the quality, financial performance and reputation of the company.

• Common knowledge of regulatory guidelines of USFDA, MHRA, EU, ANVISA, WHO, Schedule M etc. and familiarity with GMP requirements of various regulatory bodies – USFDA/ MHRA/ HPRA/ ANVISA/ TGA/ WHO/ PMDA/CDSCO.

• Collaborate with other Cluster Site Quality, SGO Heads, Supply Chain, Business Development, R&D, IT and RA for any specific requirement related to site Quality.

• Track and monitor site performance for improving quality index. Identify the key challenges and improvement areas. Discussion with site on action plan for improvement.

• Review of batch rejection, market complaint, FAR/Recalls, Invalidated OOS - Monthly tracking, review and collation of details and discussion with site Quality for action plan.

• Track and monitor Productivity / SLA /TAT from each site. Document productivity trends, Manpower analysis pending RM / PM (NMT 30 day) for release and report insights to Cluster Quality Heads.

• Support for timely implementation of Quality owned harmonized IT solutions according to plan.

• Regularly update on status of Regulatory inspection, CQA audit and upcoming inspection.

• Coordinate with site for annual revenue and capex budget proposal including new headcount proposal. Work with Cluster Head to review and submit final proposal to corporate functions (Finance/HR/MDO), with

• Identify and review Quality cost reduction initiatives as per management requirements.

• Review, discuss and track projects / initiatives /tasks (Cluster / Corporate) for completion and closure.

• Work closely with Cluster Quality Head for reviews, identifying actionable points and ensuring closures.

Experience & Knowledge:

Experience in a pharmaceutical organization with good exposure of Quality and Manufacturing Operations.

A strong knowledge of GMP’s in both domestic and international regulatory environments.

Strong communication skills and goal oriented.

Excellent negotiation skills, relational skills and ability to communicate effectively with all levels of the organization and external stakeholders.