Job Description

Contract: 12 Months with a possibility of extension

Work Schedule: Onsite 3 days per week (Monday, Tuesday, Thursday)

Requirement: Prior cGMP and Quality experience required (local candidates only)

Experience – 3 – 5 Years

Job Summary:

• The Quality Systems Specialist supports regional quality systems activities to ensure compliance with cGMPs, regulatory requirements, and internal standards.
• This role focuses on SOP management, inspection readiness, quality metrics, and cross-functional collaboration to drive continuous quality improvement.

Key Responsibilities:

• Perform core regional quality systems activities, including SOP revisions and inspection readiness support, in accordance with established procedures.
• Develop, improve, and maintain regional quality system SOPs and related documentation.
• Analyze, track, and report key quality and risk metrics; recommend and support corrective actions.
• Monitor quality systems to identify gaps, escalate issues, and support timely resolution.
• Provide project management support for quality systems initiatives and collaborate with cross-functional teams to achieve quality objectives.

Qualifications:

• Bachelor’s degree in Chemistry, Biochemistry, or a related technical discipline.
• Minimum 3 years of relevant experience in quality systems (e.g., audits and regulatory inspections, LMS/training operations, document control, electronic quality systems).
• Strong knowledge of cGMPs and applicable health authority and regional guidelines.
• Hands-on experience executing quality processes, including SOP/protocol writing, metrics monitoring, and issue resolution.
• Demonstrated strong performance in prior roles.

Functional Skills:

• Collaborative team player with the ability to consider and communicate with diverse perspectives.
• Effective communicator across all organizational levels; able to influence outcomes.
• Clear, concise, written and verbal communication tailored to the audience.
• Proactive in escalating issues and seeking support in a timely manner.

Job Tags

Similar Jobs