Kerja Sepenuh Masa, Quality Operations Engineer di Coalesce Management Consulting - Maukerja

Role Overview

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

Key Responsibilities

• Change Controls: Lead and manage change control processes, ensuring timely evaluation, documentation, and implementation in alignment with GMP requirements.
• Equipment Qualification Oversight: Provide quality oversight for equipment qualification activities (IQ/OQ/PQ), ensuring adherence to validation protocols and regulatory expectations.
• Quality Compliance: Ensure compliance with company SOPs, industry guidelines, and regulatory requirements (e.g., FDA, EMA, PIC/S).
• Cross-Functional Collaboration: Partner with engineering, manufacturing, and validation teams to support continuous improvement initiatives.
• Documentation & Reporting: Review and approve qualification protocols, reports, and change control documentation.
• Audit Support: Assist in internal and external audits, providing subject matter expertise on change control and equipment qualification processes.

Qualifications & Experience

• Bachelor’s degree in Engineering, Life Sciences, or related discipline.
• Minimum 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 provide leadership in quality oversight.

Preferred Attributes

• Experience in sterile manufacturing or complex pharmaceutical environments.
• Familiarity with electronic quality management systems (eQMS).