Senior Manager - Section Head Quality Compliance

Sun Pharma; Dadra and Nagar Haveli and Daman and Diu; Vor Ort; INR 3.500.000 - 5.200.000; Vollzeit

Zusammenfassung

Sun Pharma invites an experienced Senior Manager - Section Head Quality Compliance to lead regulatory compliance in Global Quality & Compliance. Based in Dadra, you will drive GMP/GDP adherence, data integrity, audits, CAPA, and risk assessments while coordinating inspections and preparing audit responses.

You will provide technical writing, metrics, and governance through dashboards and management reviews, ensuring strict regulatory alignment across US FDA, EU HC, and other authorities.

Qualifikationen

• Strong knowledge of GMP, GDP, ICH Guidelines, WHO Guidelines, US FDA Regulations (21 CFR Parts 210, 211).
• Data Integrity Requirements and Audit/inspection management.
• Root Cause Analysis, CAPA Management and Risk Assessment.
• Technical writing and report preparation; excellent communication and presentation skills.
• Prepare Quality metrics and management review reports; maintain compliance dashboards and KPIs.
• Conduct compliance risk assessments and identify gaps with mitigation plans.
• Plan and conduct internal compliance audits; coordinate inspections.

Aufgaben

• Strong knowledge of: GMP, GDP, ICH Guidelines, WHO Guidelines, US FDA Regulations (21 CFR Parts 210, 211). Data Integrity Requirements, Audit and inspection management, Root Cause Analysis, CAPA Management and Risk Assessment.
• Technical writing and report preparation; excellent communication and presentation skills.
• Prepare Quality metrics and management review reports.
• Maintain compliance dashboards and KPIs.
• Conduct compliance risk assessments.
• Identify compliance gaps and develop mitigation plans.
• Plan and conduct internal compliance audits.
• Coordinate customer, corporate, and regulatory inspections.
• Prepare responses to audit observations.
• Track compliance commitments and effectiveness of corrective actions.
• Must have demonstrated experience handling regulatory audits and inspections, like USFDA, EU, HC, TGA etc

Kenntnisse

GMP knowledge

GDP knowledge

ICH Guidelines

WHO Guidelines

US FDA Regulations

Data Integrity

Audit & Inspection Management

Root Cause Analysis

CAPA Management

Risk Assessment

Technical writing

Report preparation

Communication & presentation

Ausbildung

B.Pharm

M.Pharm

Jobbeschreibung

Job Description:

Job Title:

Senior Manager - Section Head Quality Compliance

Business Unit:

Global Quality & Compliance

Job Grade

Senior Manager

Location :

Dadra

At Sun Pharma, we commit to helping you “Create your own sunshine”— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community.

Are You Ready to Create Your Own Sunshine?

As you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous progress. Exhibit self-drive as you ‘Take charge’ and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we ‘Thrive together’ and support each other’s journeys.”

Key responsibilities:

• 1. Strong knowledge of: GMP, GDP, ICH Guidelines, WHO Guidelines, US FDA Regulations (21 CFR Parts 210, 211). Data Integrity Requirements, Audit and inspection management, Root Cause Analysis, CAPA Management and Risk Assessment,
• 2. Technical writing and report preparation, Excellent communication and presentation skills.
• 3. Prepare Quality metrics and management review reports.
• 4. Maintain compliance dashboards and KPIs.
• 5. Conduct compliance risk assessments.
• 6. Identify compliance gaps and develop mitigation plans.
• 7. Plan and conduct internal compliance audits.
• 8. Coordinate customer, corporate, and regulatory inspections.
• 9. Prepare responses to audit observations.
• 10. Track compliance commitments and effectiveness of corrective actions.
• 11. Must have demonstrated experience handling regulatory audits and inspections, like USFDA, EU, HC, TGA etc

Travel Estimate:

Job Requirements:

Educational Qualification

B,Pharm/ M.Pharm

Experience

15+ Years

Your Success Matters to Us

At Sun Pharma, your success and well-being are our top priorities! We provide robust benefits and opportunities to foster personal and professional growth. Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Let’s create a brighter future together!

Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).