Overview
QA Specialist/Pharma MNC, #HYN Jobs in Singapore, Singapore at Recruit Express Pte Ltd.
QA Specialist (Pharma MNC, Contract) #HYNJOB SCOPE Responsible to review and approve master batch records and subsequent batch records associated with the manufacturing, packaging and labeling of intermediates and active pharmaceutical ingredients (API) to ensure batches produced are in compliance with quality standards and regulatory registered specifications.
Review QC lab worksheets for intermediates, APIs and cleaning samples.
Disposition of the intermediates and active pharmaceutical ingredients (API), including re-evaluation.
Review and approve cleaning records and procedures and ensure compliance with the Quality Standards (PQS) and guidelines.
Support production startup activities including new product introduction (NPI), changeover activities, equipment releases, module clearance etc.
Tank farm monitoring and QA oversight of the solvent recovery processes.
Review and approve GMP documentation and ensure their compliance to Quality Standards (PQS).Ensure adherence to quality procedures, regulatory requirements and cGMPs.Perform Quality Impact assessment for Change control.
Act as label administrator and manage Category 1 manual labels according to stipulated procedure. Perform quality review of material master data setup in SAP and create label template for intermediates and APIs.Write deviations according to the site procedures. Ensure issues are escalated according to the Quality Standards (PQS).Coordinate with cross-functional team to prepare Annual Product Record Review, discuss trends and atypical observations and recommend improvement actions.
Support and facilitate product return process.
Support internal audits to ensure the internal controls are effective. Maintain inspection readiness and support inspections from regulatory agencies and customers. Actively participate in GMP walkdowns to ensure site operation and facility maintained in inspection ready state.
Support the maintenance of validated stated of GMP systems and processes.
Support regulatory queries in a timely manner, eg regulatory COA issuance.
QA oversight of site processes and systems e.g. pest control program, warehouse and engineering (calibration and preventive maintenance).
Continuous improvement
on quality processes and practices on site.
Train and mentor junior members (including interns) within
Quality Assurance
team.
Lead cross functional team in issue resolution.
Stand in for QA Supervisors in his/her absence.
Lead improvement of
quality assurance
systems, as necessary.
Any other tasks as assigned by manager.
REQUIREMENTA minimum of 1 year experience or internship in pharmaceutical industry or related industry.
Degree in Pharmaceutical or Chemical Engineering.
Applicants with more experience can be considered for a senior role.
HOW TO APPLY
If you are interested in exploring this role or other current openings in the market, kindly email me at  with your resume.
We regret to inform that only shortlisted candidates will be notified.
Ashley Loo Yan Ni | R2095115 | EA License Number: 99C4599
Recruit Express Pte Ltd Company Reg. No. W
#J-18808-Ljbffr
Title: QA Specialist/Pharma MNC, #HYN
Company: Recruit Express Pte Ltd.
Location: Singapore, Singapore
Category: Quality Assurance – QA/QC, Healthcare
