My client, a rapidly growing pharma company , is looking out for a Quality Assurance Associate(TEMP).
Key accountabilities
Quality oversight of Contract/External Manufacturers (CMO/ EMO)/ 3rd party logistics providers
Release of Products (Due diligence checks), evaluate product batch documentation ensuring that all batches have been released for supply in compliance with relevant regulatory and quality requirements and comply with relevant Marketing Authorisation details. To disposition goods i.e. to approve or reject, intermediate, bulk and finished products and ensure that supporting records are maintained.
To write, review &/or authorise Quality documents and procedures as defined e.g. SOPs, WIs, forms, PQR, Deviation and Quality investigation reports.
To maintain and manage Quality Management System (QMS) e.g. Change Control, Deviations & CAPA, Customer Complaints, including associated Metrics as pa rt of performance monitoring.
To conduct internal audits as required.
To support due diligence checks for new external contract manufacturers, new products and support external audits as required.
Qualifications and Experience
Minimum requirement is a tertiary qualification {BSc or equivalent) in chemistry, pharmacy or a related discipline.
Minimum of 2 to 8 years experience in the pharmaceutical/ medical device industry with at least 1 to 5 years of QA experience in the pharmaceutical industry. Seniority will be based on the experience.
Good knowledge of Good manufacturing practice {GMP).
Good knowledge of Good distribution practice (GDP) will be an advantage.
How to Apply:
Interested applicants may apply by sending in your updated r\xc3\xa9sum\xc3\xa9 (in MS Word format) to my email or apply directly:
Consultant: Tan Jun Jie
EA personnel reg. no.R1878852
EA License No. 17C8502
Additional Information
Career Level
Junior Executive
Qualification
Not Specified
Years of Experience
5 years
Job Type
Contract
Job Specializations
,
Company Overview
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Additional Company Information
Registration No.
201634573Z
EA No.
17C8502
Company Size
1 - 50 Employees
Average Processing Time
1 day
Industry
Human Resources Management / Consulting
Benefits & Others
Miscellaneous allowance, Long hours, Formal (e.g. Shirts + Ties)