Sr. Manager-MSAT (Validation)

Julphar; As Sudiyah; On-site; OMR 15,000 - 20,000; Full time

Job summary

Julphar, located in Al Buraymi, Oman, is seeking a seasoned validation engineer to manage the validation lifecycle including critical systems and quality control. The ideal candidate will have 10-15 years of relevant experience and a strong understanding of GMP and regulatory compliance.

This role entails leading cross-functional teams, ensuring adherence to quality standards, and participating in continuous improvement initiatives, while also possessing excellent leadership and communication skills.

Qualifications

• Minimum 10-15 years of experience in qualification and validation.
• Comprehensive understanding of GMP, GDP, ISO 9001 and ISO 14001.
• Strong familiarity with regulatory guidelines (e.g. FDA, WHO, EU).

Responsibilities

• Manage validation lifecycle using the V-Model approach.
• Ensure compliance and validation of quality control software.
• Collaborate with cross-functional teams for product lifecycle status.

Skills

Project Management

Computerized System Validation

Risk Management

Leadership

Regulatory Compliance

Education

Bachelor of Engineering or Master's in Science/Pharmacy

Tools

MS Office

Electronic QMS platforms

Job description

Main Responsibilities

• 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) remain in the Qualified state. Ensure the clean room qualifications meet the ISO-14644 requirements.
• Calibration activities: has full understanding about calibration activities (rationale, setting criteria and frequencies, outsourcing calibrations).
• Computerized System Validation (CSV): Ensure compliance and validation of Quality control, manufacturing and utilities-related software. Ensure that any new critical systems meet the 21 CFR part 11 requirements.
• Team Management: Assign tasks to Validation SMEs for qualification and validation activities.
• Quality & Compliance (EQMS): Handle Change Control, Deviation Investigations, CAPA, and Audit Management, providing technical expertise on validation and qualification.
• 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 of validation documents like archiving, retrieving and distribution.
• 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.
• Product Life Cycle Management: Has idea about overseeing process validation, product remediation, sterilization validation, cleaning validation, gowning qualification, visual inspection, Aseptic process simulation and transport validation.
• 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.

Core Competencies

• Highly result-oriented with an intense sense of accountability & ownership.
• High compliance adherence, strong diligence, initiative-taking, and flexibility.
• Excellent communication, interpersonal, and collaboration skills.
• Demonstrated skills in leadership and people management.
• Motivated, organized, focused & overall compliance.
• Must be able to manage tasks, plan workload effectively, prioritize, and adapt easily 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, or master’s in science/pharmacy with minimum 10-15 years of experience 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.