Role Objective / Major Purpose of the Job 1. Overall responsible for site quality/GXP compliance and Quality Management System, at Samba Unit.

- Managing all aspects of Quality Strategy Development, Implementation and Communicating directly with Global Regulatory Agencies on all regulatory matters.
- Responsible for quality system of P2P / LL operation, business development /people development and support. 1.

Principal

Tasks & Responsibilities 2. Quality activities at samba plant.
- Overall responsibilities of GMP/GLP/ regulatory compliance.
- To meet the regulatory 24X7 compliance.
- Training of QA/QC employee within departments.
- FDA/ Licensing related activity monitoring.
- 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.
- To ensure the compliance of GMP/GLP related activities of products manufacturing at Samba location.
- Develop and Implement effective and effective Quality strategies to bring products to market (Domestic & International).
- Ensure the company is in full compliance with regulatory agencies.
- Serve as the key contact for regulatory agency, notified body and customer / regulatory audits of the facilities.
- Develop and Implement efficient and effective Quality strategies to bring products to market (Domestic & International).
- Identify relevant quality standards for product development, manufacturing and defining 14. design requirement for domestic and international markets.
- Ensure the company is in full compliance with regulatory agencies.
- To ensure CGLP compliance and ensure all SOP related to Quality system (QA/QC) prepared, reviewed and implemented properly.
- Promote the development of a facility –wide understanding of the key elements related to quality system and regulatory compliance requirements.
- To ensure timely qualification of equipments , instruments, preventive maintenance,



Annual maintenance and calibration of the instruments.
- Effectively lead and manage department Quality personnel.
- 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.
- Determining the root cause of problems that involves compliance with Regulatory/ Domestic requirements.
- Overseeing the corrective and preventive actions for the problems 23.

Conducting

Recall 24. Handling preparation and follow up for GMP Inspections.
- Keep a regulatory watch and inform the departments concerned of any regulatory changes.
- Identify ways to continuously improve quality and compliance with regulations and company standards, policies and procedures.
- Training of SOP as per the Training schedule.
- Arranging the training and troubleshooting session of the instrumentation for the instruments application engineer for related instruments.
- To train the analyst for GLP aspects in laboratory.
- Any other responsibility assigned by management.
- 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.

- 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

📌 Assistant General Manager (Jammu)
🏢 Cadila Pharmaceuticals
📍 Jammu