Quality Assurance Specialist (6months/PHARMA MNC) - West/up to $4.5k/Entry Level #HAO

Recruit Express; Singapore; On-site; SGD 60,000 - 80,000; Full time

Job summary

A healthcare staffing agency in Singapore is seeking a qualified candidate for a GMP compliance role. You will review documentation, manage vendors, and conduct audits to ensure compliance. Candidates should have a degree in Life Sciences and at least one year of relevant experience in a GMP environment. The position offers a salary of up to $4.5K plus transport allowance.

Qualifications

• Minimum 1 year of relevant experience in a GMP/manufacturing environment.

Responsibilities

• Review and approve GMP documentation.
• Conduct internal and external audits.
• Manage logistics for GMP inspections.

Skills

GMP compliance

Vendor management

Internal audits

Safety initiatives

Education

Degree in Life Sciences

Job description

Salary: up to $4.5K + 250 transport allowance

Duration: 6 months

Working Days & Hours: Mon-Fri Office Hours

Location: Tuas (islandwide pickup)

Job Description

• Review and approve GMP documentation to ensure their compliance with PQS.
• Qualify and manage vendors according to PQS and maintain accurate records of vendor status. Review and analyze the quality related issues from vendors and recommend improvement actions to mitigate compliance risks. Ensure vendors and materials are qualified as required to support production schedule.
• Conduct internal audits to ensure internal controls are effective. Conduct external audits to ensure adequate oversight to vendors and collaborate with vendor to reduce material quality issues.
• Manage logistics for internal and external GMP inspections, including site communications and training.
• Maintain inspection readiness and support inspections from regulatory agencies and customers. Actively participate in GMP walk downs to ensure site operation and facility maintained in inspection ready state and adhere to site procedures and PQS.
• Facilitate and prepare regulatory submissions and attend to regulatory queries in a timely manner.
• Ensure gap analysis of site procedures against PQS is performed by relevant SMEs in a timely manner meeting requirements for rollout of new / updated PQS / Policy Memos.
• Participate in gap analysis of site procedures against PQS and propose required actions to address identified gaps and mitigate risks.
• Maintain current quality tracking systems and quality metrics to proactively identify trends and atypical observations.
• Support preparation and/or coordination of site monthly and adhoc Site Quality Review Team (SQRT) meetings.
• Uphold code of conduct and values.
• Play an active and impactful role in Tier processes by updating performance against metrics, highlighting & resolving issues, with appropriate escalations.
• Collaborate with cross-functional teams to drive flawless execution.
• Actively participate in Safety initiatives, and perform investigation related to EHS (as needed).

Job Requirements

Min Degree in Life Sciences or similar & min 1 yr of relevant experience in GMP/manufacturing environment

Contact

Interested candidates, please submit your resume to: [e-mail]

Ally Audrey Lok Xin Woon

Recruit Express Pte Ltd (Healthcare & Lifescience)

Company EA Licence number : 99C4599

Personnel EA License: R21102307

[e-mail]