Review and approve GMP documentation and ensure their compliance to Company Quality Standards .
Ensure adherence to quality procedures, regulatory requirements and GMPs.
Improve quality assurance systems, as necessary.
Maintain current quality tracking systems and the quality metrics to proactively identify trends and atypical observations.
Conduct internal audits to ensure the internal controls are effective. Conduct external audits to ensure adequate oversight to suppliers and collaborate with supplier to reduce starting material quality issues.
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
Support the maintenance of validated stated of GMP systems and processes.
Facilitate and prepare regulatory submissions and attend to regulatory queries in a timely manner
Qualify and manage suppliers according to Company Quality Standards and maintain accurate records of supplier: status.
Review and analyze the quality related issues from suppliers and recommend improvement action to mitigate compliance risk to the company.
Requirement
Min. Diploma / Degree in Science / Chemical Engineer
Min. 3 year of experience in QA in Pharma industry
If you meet the requirements of this role, please email to alexgoh@recruitexpress.com.sg
\xe2\x9e\x96 Alex Goh Hock Leong (CEI.No: R1763413 l Recruit Express Pte Ltd (Healthcare & Life Science) | 99C4599) alexgoh@recruitexpress.com.sg Telegram me @alexgohhl
Industry
Healthcare / Pharmaceutical / Life Science / Medical Device
Specialization
Healthcare - Pharmaceutical / Life Science / Medical Device / Clinical Research / Regulatory Affairs Legal & Compliance
Location
West
Employment Type
Contract / Temp
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 to alexgoh@recruitexpress.com.sg
\xe2\x9e\x96 Alex Goh Hock Leong (CEI.No: R1763413 l Recruit Express Pte Ltd (Healthcare & Life Science) | 99C4599) alexgoh@recruitexpress.com.sg
*All information will be treated with strictest confidence. We regret that only short-listed applicants will be notified.