Job Description

Description

Responsibilities:

• 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.

• Play an active and impactful role in Tier processes by updating performance against metrics, highlighting & resolving issues, with appropriate escalations. Develop courses of action and drive implementation of solutions.

• Collaborate with cross-functional teams to drive flawless execution.

• Mentor junior members (including interns) within the Quality Assurance team.

• Actively participate in Safety initiatives, and perform investigation related to EHS (as needed).

Education:

• Degree in Chemistry, Microbiology, Engineering or other Science related discipline.

• Diploma in Science related discipline with a minimum of 6-8 years of experience in Quality Assurance role within the pharmaceutical industry will be considered.

Experience:

• Minimum 4 years experience (including Quality Assurance roles) within the pharmaceutical industry.

• Compliance, regulatory or GMP audit experience is an advantage.

• Strong written and oral communication skills.

• Demonstrated personal leadership, accountability, and organizational skills with a proven ability to operate independently with minimal supervision. Experience working in a cross-functional, matrix environment is an advantage.

If you are interested in the position, do kindly drop your most updated resume to
Thank You!

Lynn Ho
R23114223

Recruiter\'s Ref Code: #HHO
Recruit Express Pte Ltd (Healthcare & Lifesciences Division)
EA License: 99C4599

Industry

Healthcare / Pharmaceutical / Life Science / Medical Device
Others
Public Sector / Government & Statutory Boards
Semiconductor / Electronics / Engineering

Specialization

Chemist / Research Scientist
Engineering
Healthcare - Pharmaceutical / Life Science / Medical Device / Clinical Research / Regulatory Affairs

Location

Central, North, East, West

Employment Type

Contract / Temp
Permanent

Salary

S$4,001 - S$6,000 / mth
S$6,001 to S$10,000 / mth

If you meet the requirements of this role, please email a detailed resume in Word document to Lynn Ho Lin Ying.
CEI Registration No.: R23114223
Email: lynnho@recruitexpress.com.sg

*All information will be treated with strictest confidence. We regret that only short-listed applicants will be notified.

Recruit Express