Manager – R&D Quality (GCP QA)
Sun R&D Quality
Location: Tandalja
Company: Sun Pharmaceutical Industries Ltd
Job Grade: G11A / G10
Business Unit: Sun R&D Quality
Work Mode: Office-based with ~6–8 days/month travel
Company Overview
Sun Pharmaceutical Industries Ltd is a global pharmaceutical leader with strong capabilities in R&D, clinical development, and regulated market operations.
Key Focus Areas
Generic and specialty pharmaceuticals
Clinical research and BA/BE studies
Regulatory-compliant drug development
Global quality systems and compliance
Strong presence across regulated markets
Job Summary
The Manager – R&D Quality (GCP QA) is responsible for ensuring Good Clinical Practice (GCP) compliance across in-house and outsourced clinical and BA/BE studies.
The role focuses on:
Clinical quality assurance oversight
Audit planning and execution
CRO and clinical site qualification
Regulatory inspection readiness
CAPA management and quality system harmonization
GCP compliance across R&D studies
Key Responsibilities
1. Quality System Development & Governance
Review and develop QA SOPs and Global Quality Systems (GQS/GSOPs)
Harmonize QA systems across in-house and outsourced BA/BE studies
Collaborate with stakeholders for system implementation and updates
2. GCP Audit Execution
Conduct audits for:
BA/BE studies (healthy volunteers and patient-based)
Investigator sites (Site Selection Visits – SSVs)
Trial Master Files (TMF audits)
Study documentation (retrospective audits)
In-process clinical study audits
Purpose:
Identify compliance gaps
Assess adherence to protocols, regulations, and SOPs
Recommend corrective actions
3. CRO / CSP Qualification & Oversight
Conduct qualification and re-qualification audits of:
CROs (Contract Research Organizations)
CSPs (Contract Service Providers)
Evaluate vendor compliance and performance standards
4. CAPA Management
Review adequacy of CAPA plans
Ensure implementation and effectiveness checks
Address findings from:
Internal audits
Corporate audits
Regulatory inspections
5. Study Documentation Review
Review key clinical study documents:
Protocols
Informed Consent Forms (ICFs)
Investigator Brochures (IBs)
Clinical Study Reports (CSRs)
Ensure compliance with:
GCP guidelines
Good Documentation Practices (GDP)
6. Regulatory Inspection Support
Support regulatory inspections for clinical studies
Coordinate responses to regulatory queries
Develop and implement CAPA for inspection findings
Ensure timely closure of regulatory issues
7. Regulatory & GCP Intelligence
Stay updated on:
Global GCP regulations
Clinical research guidelines
Provide guidance on compliance implementation across studies
8. Team Leadership & Mentoring
Mentor and coach QA team members
Provide performance feedback and training
Support skill development in audit and compliance functions
Experience Requirements
Minimum 10 years of experience in GCP environment
At least 6 years in Quality Assurance (QA)
Experience in:
Clinical audits
BA/BE studies
CRO qualification
Regulatory inspections
Outsourced clinical study management
Educational Qualification
Graduate or Postgraduate degree in Basic Sciences or related field
Technical Skills
GCP & Clinical Quality Systems
Strong knowledge of:
ICH-GCP guidelines
Global clinical trial regulations
BA/BE study requirements
Audit & Compliance Expertise
Clinical site audits
TMF audits
CRO/CSP audits
Internal and external regulatory audits
Regulatory & Inspection Readiness
Handling regulatory agency inspections
CAPA design and effectiveness verification
Compliance gap analysis
Systems & Documentation
Clinical study documentation review
SOP development and harmonization
Quality management systems in clinical research
Behavioral Competencies
Strong results orientation
Customer-centric and problem-solving mindset
Excellent communication skills across all levels
Independent decision-making ability
Leadership and team mentoring capability
Analytical and structured thinking
High attention to regulatory detail
Travel Requirements
6–8 days per month travel
Includes:
Site audits
CRO/vendor audits
Clinical study inspections and oversight
Work Culture
Sun Pharmaceutical Industries Ltd promotes:
Strong compliance-driven culture
Continuous improvement mindset
Collaboration across global R&D teams
Ownership and accountability
Scientific and regulatory excellence
Role Summary (Simple View)
This is a senior clinical quality assurance role focused on:
Auditing clinical trials (BA/BE studies)
Ensuring GCP compliance across vendors and sites
Managing CAPA and regulatory inspections
Strengthening clinical quality systems in R&D
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