A Highly renowned and fast growing pharmaceutical organisation is looking for an experienced DGM - GM Compliance to drive compliance governance across multiple manufacturing sites.
- Location: Mumbai Level: DGM / GM Corporate Compliance
CTC: 40 to 50 LPA, depending on current package, Skill set and experience
Reporting to: Director
- Extensive travel across manufacturing sites will be involved
Key Responsibilities:
- Data Integrity &
• Compliance Governance
- Implement data integrity governance and compliance across all sites of the company.
- Risk Management &
• Internal Controls
- Influence business units to manage risk, improve internal controls, and develop compliant business solutions.
- Monitoring &
• Assessment
- Continuously monitor internal and external environments to identify key risks, gaps, and compliance issues.
- Regulatory Audits &
• System Checks
- Ensure systems and procedures align with regulations (USFDA, MHRA, EDOM, GAMP5, PICs, TGA) through audits.
- Review quality management systems (Change control, Deviation, CAPA, Complaints, Recalls, OOS/OOT) via audits.
- Audit computer system validation processes.
- Site Compliance Health
- Independently assess compliance health of each site using a risk-based approach.
- Policy &
• Procedure Development
- Advise on and support the development and implementation of departmental procedures and compliance policies.
- Corrective &
• Preventive Actions
- Assist teams in assessing and implementing corrective and preventive actions.
- Training &
• Awareness
- Facilitate compliance training at sites.
- Design and prepare training modules on technical, compliance, regulatory, and soft skill topics.
- Site Operations &
• Hot Spot Identification
- Identify compliance hot spots and conduct unit operations to verify compliance levels.
- Coordination of Compliance Activities
- Coordinate all compliance-related activities across all manufacturing sites of the company, including training, procedures, communications, reporting, auditing, monitoring, enforcement, discipline, and investigations.
- Material &
• Department Audits
- Audit starting and packing materials as per EU GMP and ICH guidelines.
- Audit finished dosage forms as per cGMP, EU GMP, and ICH guidelines.
- Audit the Pharmacovigilance department as per Positive Pharmacovigilance Practices, EMA GVP, and ICH guidelines.
Ideal Profile: A senior pharmaceutical quality/compliance professional with strong experience in corporate compliance, regulatory audits, QMS, data integrity and multi-site manufacturing operations, with the ability to independently assess risks and influence site leadership.
Those of you whose profile matches the above mentioned description and would like to apply for this position shall forward their updated resume to
[email protected] In case of a query, Please feel free to speak to the undersigned:
Sudhir Vinayak,
Director, Pharma Placements Inc.
Mobile: 98202 34987
📌 DGM / GM Compliance (Pharma Industry) (Mumbai)
🏢 Pharma Placements
📍 Mumbai