Sr. Manager - Quality MSAT

Julphar; Ras Al Khaimah; Presencial; AED 300.000 - 420.000; Jornada completa

Descripción de la vacante

Julphar, a leading pharmaceutical company in the United Arab Emirates, seeks a senior Validation and Quality Systems expert to lead equipment and utilities qualification, CSV, calibration, and GMP compliance.

You will oversee cross-functional teams, ensure regulatory alignment (FDA, WHO, EU), maintain EQMS data integrity, and drive continuous improvement and risk management across quality systems.

Formación

• Bachelor’s degree in Engineering, Science, or Pharmacy.
• Minimum 10 years of experience in equipment/facilities qualification and validation.
• GMP, GDP, ISO 9001 and ISO 14001 knowledge.
• Familiar with FDA, WHO, EU guidelines and 21 CFR Part 11.

Responsabilidades

• Lead qualification lifecycle for equipment, facilities, and utilities (URS to PQ).
• Ensure critical utilities remain qualified (PW, WFI, compressed air, nitrogen).
• Oversee cleanroom qualification per ISO 14644.
• Lead CSV validation for QC, Manufacturing, and Utilities.
• Maintain validated systems and data integrity (ALCOA+).
• Manage Change Controls, Deviation Investigations, CAPA via EQMS.
• Coordinate cross-functional teams and document management.
• Drive continuous improvement and risk management initiatives.
• Ensure GMP and regulatory compliance and support inspections.
• Promote EHS practices per ISO 14001:2015.

Conocimientos

Equipment qualification

Facilities qualification

Calibration management

Validation lifecycle

Computerized System Validation

GMP knowledge

GDP knowledge

Regulatory guidelines

Risk management

Leadership

Data integrity

ALCOA+

Educación

Bachelor's degree in Engineering, Science, or Pharmacy

Herramientas

EQMS

Microsoft Office

GxP systems

Descripción del empleo

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At Julphar, we are on a journey of culture transformation & our mission is to provide a better quality of life for the entire family by delivering best in class solutions and real value with compassion and professionalism.

Our core values: Respect, Collaboration, innovation, Integrity and Compassion - Combined with a focus on diversity, inclusion, and equal opportunities - are key drivers in our aim to make a positive impact on the lives of the patients we serve, enable Talents , create a healthy work environment, and accomplish our goals through world-class research and with the compassion and commitment of our employees.

Main Responsibilities

1. Equipment, Facilities & Utilities Qualification

Lead and manage the end-to-end qualification lifecycle of equipment, facilities, and utilities, following the V-Model approach, from User Requirement Specifications (URS) and technical evaluations through Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and periodic requalification.

Ensure that critical utilities, including Purified Water, Water for Injection (WFI), compressed air, and nitrogen gases, remain in a qualified and compliant state.

Oversee cleanroom qualification and ensure compliance with ISO 14644 requirements.

2. Computerized System Validation (CSV)

Lead and oversee the validation of computerized systems supporting Quality Control, Manufacturing, and Utilities operations.

Ensure computerized systems comply with applicable regulatory requirements, including 21 CFR Part 11 for relevant critical systems.

Maintain validated systems throughout their lifecycle, ensuring data integrity and regulatory compliance.

3. Calibration Management

Oversee calibration activities for instruments and equipment, ensuring accuracy, reliability, and compliance with approved procedures and applicable standards.

Ensure calibration schedules are maintained and deviations are addressed in a timely manner.

Lead, coordinate, and allocate responsibilities to Validation Subject Matter Experts (SMEs), ensuring effective execution of qualification and validation activities.

Provide technical guidance, monitor team performance, and ensure timely completion of assigned activities.

Support capability development and continuous improvement within the team.

5. Quality Management & Regulatory Compliance

Provide technical expertise and support in managing Change Controls, Deviation Investigations, Corrective and Preventive Actions (CAPA), and audit activities through the Electronic Quality Management System (EQMS).

Ensure validation and qualification activities are conducted in accordance with GMP requirements, internal quality standards, and applicable regulatory guidelines.

Support internal, external, and regulatory inspections and audits.

6. Cross-Functional Coordination & Documentation Management

Collaborate with cross-functional teams to ensure alignment on validation activities, product lifecycle requirements, and applicable country-specific regulatory and registration requirements.

Communicate validation progress, compliance updates, and potential risks to relevant stakeholders, ensuring timely follow-up and resolution.

Ensure proper management, control, archiving, retrieval, and distribution of validation and qualification documentation.

7. Continuous Improvement, Risk Management & Data Integrity

Lead and participate in quality improvement initiatives and risk management projects related to qualification and validation.

Identify compliance gaps, assess associated risks, and implement effective and sustainable corrective solutions.

Ensure the consistent application of data integrity principles, including ALCOA+, across relevant quality systems and processes.

8. Environmental, Health & Safety (EHS)

Comply with the company's Environmental Management System (ISO 14001:2015), EHS policies, and applicable workplace safety requirements.

Identify, minimize, and prevent environmental impacts and operational risks associated with daily activities.

Promote safe working practices, including proper waste disposal and safe handling and use of equipment.

Report hazards, incidents, non-conformities, and environmental concerns, and actively contribute to EHS audits and continual improvement initiatives.

Qualifications

Bachelor's degree in Engineering, Science, or Pharmacy.

Minimum of 10 years of relevant professional experience in equipment qualification, utilities qualification, calibration, and validation within the pharmaceutical or regulated manufacturing industry.

Comprehensive knowledge of Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), ISO 9001, and ISO 14001 requirements.

Strong understanding of applicable regulatory guidelines and standards, including FDA, WHO, and EU requirements.

Demonstrated experience in computerized system validation (CSV), qualification lifecycle management, and calibration systems.

Practical experience in quality management systems, audits, deviation investigations, CAPA, and risk management.

Proven leadership experience, with the ability to manage technical teams and coordinate cross-functional activities.

Strong analytical, problem-solving, communication, and decision-making skills.

Proficiency in Microsoft Office applications and electronic Quality Management Systems (EQMS).

We value people from different backgrounds. Could this be your story? or visit www.Julphar.net to read more about us and the journey of Julphar