Manager- CAPA Effectiveness

Job Description

Position:

Manager: CAPA Effectiveness

Job Title:

Manager: CAPA Effectiveness

Job Grade:

G10

Function:

Global Quality and Compliance

Sub-function:

Corporate Quality Audit

Manager s Job

Title:

Lead - CAPA Effectiveness

Skip Level Manager s Title:

Function Head

Title:

Location:

Tandalja (Baroda R&D)

No. of Direct Reports (if any)

Job Summary

Areas of Responsibility

• To conduct the CAPA effectiveness review activities at manufacturing sites of Sun Pharma as per the review plan
• To perform CAPA effectiveness review for CAPAs provided to Regulatory Authorities.
• To perform review of implementation status of Global CAPA across Sun manufacturing sites.
• To inform CAPA effectiveness review outcome to Lead / HOD and prepare CAPA effectiveness review report within stipulated timeline.
• Participate in Regulatory Audit Review activities of manufacturing sites of Sun Pharma, need basis.
• Sound knowledge of current regulatory requirements/expectations
• Effective interpersonal, communication and organizational skill
• Participate and support project work as allocated by reporting authority

Travel Estimate

Job Scope

Internal Interactions (within the organization)

External Interactions (outside the organization)

Geographical Scope

Financial Accountability (cost/revenue with exclusive authority)

Job Requirements

Educational Qualification

B. Pharma or M. Pharma

Specific Certification

Skills

QA Background, Knowledge of QMS or Compliance, US FDA experience is require.
OSD and Sterile experience is require - sterile will be preferable

Experience

10 to 16 years of work experience.

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

A strong knowledge of GMP s and regulatory audits, CAPA assessments in international regulatory environments.