Quality Operations Engineer

About the role

We are seeking a dedicated Quality Operations Engineer to join our pharmaceutical operations team. The role focuses on managing change controls and providing quality oversight for equipment qualification activities, ensuring compliance with regulatory standards and internal quality systems.

Key responsibilities

• Lead and manage change control processes in line with GMP requirements.
• Provide quality oversight for equipment qualification (IQ/OQ/PQ) and ensure adherence to validation protocols.
• Ensure compliance with company SOPs, industry guidelines, and regulatory requirements such as FDA, EMA, and PIC/S.
• Collaborate with engineering, manufacturing, and validation teams to support continuous improvement.
• Review and approve qualification protocols, reports, and change control documentation.
• Assist in internal and external audits, offering expertise on change control and equipment qualification.

Required profile

• Bachelor’s degree in Engineering, Life Sciences, or a related discipline.
• 5–8 years of experience in pharmaceutical quality operations or validation.
• Strong knowledge of GMP, GxP, and regulatory requirements.
• Hands‑on experience with change control systems and equipment qualification.
• Excellent communication and stakeholder management skills.
• Ability to work independently and lead quality oversight.

Required skills

• Good Manufacturing Practice (GMP)
• Good Practice (GxP) standards
• Regulatory frameworks: FDA, EMA, PIC/S
• Change control systems
• Equipment qualification processes (IQ, OQ, PQ)
• Electronic Quality Management Systems (eQMS)