Manager-MSAT (Validation)

Main Responsibilities:

1. Equipment, Facilities, and Utilities Qualification: Manage the validation lifecycle using the V-Model approach, from User Requirement Specification (URS) to technical evaluation, Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT) Initial qualification (IQ, OQ & PQ), Requalification. Ensuring the Utilities (Purified Water, Water for injection, Compressed gases & Nitrogen Gases) in the Qualified state. Ensure the clean room Qualifications shall meets the ISO-14644 requirements.
2. Calibration activities: has full understanding about calibration activities (rational, setting criteria and frequencies, outsourcing calibrations.
3. Computerized System Validation (CSV): Ensure compliance and validation of Quality control, manufacturing and utilities-related software. Ensure that any new critical systems shall meet the 21 CFR part 11 requirements.
4. Team Management: Assign tasks to Validation SMEs for qualification and validation activities.
5. Quality & Compliance (EQMS): Handle Change Control, Deviation Investigations, CAPA, and Audit Management, providing technical expertise on validation and qualification.
6. Cross-Functional Coordination:

• Collaborate with cross-functional teams (CFTs) to track product lifecycle status and ensure compliance with country-specific registration requirements. Communicate updates to stakeholders for necessary action.
• Responsible for management for validation documents like archiving, retrieving and distribution.

1. Continuous Improvement and Risk Management:

• Lead or participate in quality improvement and risk management projects.
• Identify compliance gaps and propose systematic solutions.
• Ensure proper implementation of data integrity principles (ALCOA+) across all quality systems.

1. Product Life Cycle Management: has idea about oversee process validation, product remediation, sterilization validation, cleaning validation, gowning qualification, visual inspection, Aseptic process simulation and transport validation.
2. Environmental, Health and Safety Responsibilities:

• Follow the company’s Environmental Management System (ISO 14001:2015) and HSE policies in daily work.
• Actively minimize environmental impacts, maintain a safe workplace, and handle tasks responsibly (e.g. proper disposal of waste, safe use of equipment).
• Report hazards, non-conformities, or environmental issues to supervisors and support continual improvement initial.

Core Competencies:

• In terms of competency, you are highly result-oriented with an intense sense of accountability & ownership.
• High compliance adherence, having strong diligence, initiative-taking, and flexibility.
• Excellent communication, interpersonal, and collaboration skills.
• Having demonstrated skills in leadership and people management
• Motivated, organized, focused & overall compliance.
• Must be able to manage tasks, plan workload effectively, prioritize, and easily adapt to changing situations.
• Identify, reduce, and prevent environmental impacts and operational risks.
• Contribute to EHS activities, audits, and continual improvement initiatives.

Qualification/Functional Knowledge:

• Bachelor of engineering (Mechanical/Electrical, or Mechatronic), pharmacy/ master’s in science/pharmacy with minimum work experience of 10-15 years in qualification and validation.
• Comprehensive understanding of GMP, GDP, ISO 9001 and ISO 14001 requirements.
• Strong familiarity with regulatory guidelines (e.g. FDA, WHO, EU).
• Experience in audits, CAPA, risk management, and QMS systems.
• Excellent leadership and team management skills.
• Analytical thinking and problem-solving skills.
• Proficiency in MS Office and electronic QMS platforms