Assistant General Manager

Role Objective / Major Purpose of the Job
1. Overall responsible for site quality/GXP compliance and Quality Management System, at Samba Unit.
2. Managing all aspects of Quality Strategy Development, Implementation and Communicating directly with Global Regulatory Agencies on all regulatory matters.
3. Responsible for quality system of P2P / LL operation, business development /people development and support.

1. Principal Tasks & Responsibilities
2. Quality activities at samba plant.
3. Overall responsibilities of GMP/GLP/ regulatory compliance.
4. To meet the regulatory 24X7 compliance.
5. Training of QA/QC employee within departments.
6. FDA/ Licensing related activity monitoring.
7. To ensure and accurate reliable efficient and timely testing of finished products, Raw material, Packing materials, in process and process validation sample and release and reject of the same.

8. To ensure the compliance of GMP/GLP related activities of products manufacturing at Samba location.
9. Develop and Implement efficient and effective Quality strategies to bring products to market (Domestic & International).
10. Ensure the company is in full compliance with regulatory agencies.
11. Serve as the key contact for regulatory agency, notified body and customer / regulatory audits of the facilities.
12. Develop and Implement efficient and effective Quality strategies to bring products to market (Domestic & International).
13. Identify relevant quality standards for product development, manufacturing and defining
14. design requirement for domestic and international markets.
15. Ensure the company is in full compliance with regulatory agencies.
16. To ensure CGLP compliance and ensure all SOP related to Quality system (QA/QC) prepared, reviewed and implemented properly.
17. Promote the development of a facility –wide understanding of the key elements related to quality system and regulatory compliance requirements.
18. To ensure timely qualification of equipments , instruments, preventive maintenance, Annual maintenance and calibration of the instruments.
19. Effectively lead and manage department Quality personnel.
20. As a member of the senior management team, provide sound advice and guidance regarding the impact of regulatory and quality issues on overall corporate strategy and operations.
21. Determining the root cause of problems that involves compliance with Regulatory/ Domestic requirements.
22. Overseeing the corrective and preventive actions for the problems
23. Conducting Recall
24. Handling preparation and follow up for GMP Inspections.
25. Keep a regulatory watch and inform the departments concerned of any regulatory changes.
26. Identify ways to continuously improve quality and compliance with regulations and company standards, policies and procedures.
27. Training of SOP as per the Training schedule.
28. Arranging the training and troubleshooting session of the instrumentation for the instruments application engineer for related instruments.
29. To train the analyst for GLP aspects in laboratory.
30. Any other responsibility assigned by management.
31. To provide safe environment in quality department and support EHS policy of the company.

Key Skills & Competencies
Functional / Technical:
1. Batch Release Authority: Ultimate accountability for reviewing and market-releasing or rejecting finished product batches.
2. Risk Management: Expert application of ICH Q9 Quality Risk Management principles to mitigate product failures.
3. Vendor Quality Management: Leading external audits, qualification of API/excipient suppliers, and technical agreements.
4. Product Quality Reviews (PQR/APQR): Analyzing annual trends to identify systemic product and process variations
5. Global Regulatory Mastery: Deep expertise in USFDA, MHRA, EU-GMP, and WHO regulations.
6. QMS Governance: Advanced control over deviations, CAPA, Out of Specification (OOS), and change control.
7. Audit Defense: Proven ability to lead and defend face-to-face inspections by global regulators.
8. Data Integrity Assurance: Enforcing strict ALCOA+ principles across all manual and digital systems.
9. Validation & Qualification: Oversight of equipment, process, software (GAMP 5), and analytical method validation.
10. Laboratory Governance: Technical oversight of Quality Control (QC) equipment like HPLC, GC, and stability chambers
Behavioural:
1. Uncompromising Integrity: Standing firm on compliance decisions and batch rejections despite corporate commercial or timeline pressures.
2. High-Stakes Resilience: Maintaining absolute composure, clarity, and authority during intense regulatory audits
3. Strategic Influence: Persuading senior leadership and cross-functional teams to invest in quality systems and embrace a proactive compliance culture.
4. Meticulous Objectivity: Analyzing deviations and product failures using pure data, root-cause logic, and risk assessment rather than assumptions.
5. Assertive Decision-Making: Taking swift, definitive action to halt production or quarantine batches when patient safety or data integrity is compromised.
6. Cohesive Collaboration: Breaking down silos between Quality Assurance, Quality Control, and Production to solve operational issues collectively.
7. Mentorship & Talent Development: Building a highly capable, future-ready compliance team through active coaching, technical training, and empowerment.
8. Continuous Quality Mindset: Fostering an organizational culture where quality is viewed as a shared daily habit rather than an inspection-driven task