Senior QA Specialist

2 days ago


Singapore INTEGRITY PARTNERS PTE. LTD. Full time

**THE COMPANY**:
Partnering with a well-established principal **Pharmaceutical MNC **known for their innovation in major therapeutic areas, our client is seeking a **Senior Quality Assurance Specialist **to join their team.

If you have passion for quality assurance in the pharmaceutical field, this will be a great opportunity to further develop yourself in this industry. You should exhibit strong interpersonal skills, and able to work independently and collaboratively with cross-functional departments.

**REQUIREMENTS**:

- At least **3-5 years **of QA experience in the pharmaceutical industry or pharmaceutical manufacturing environment
- Relevant science degree (e.g. Pharmacy, Biomedical Sciences)
- **Good knowledge of GxP **(Good Distribution Practice and/or Good Manufacturing Practice)

**PRIMARY RESPONSIBILITIES**:

- To develop and implement QA processes, aligned with local and global requirements
- Effective operational implements of the QMS appropriate to the GxP discipline.
- Ensure GxP compliance status is visible to GxP Country Quality Lead and assure that gaps are addressed appropriately to mitigate risk.
- Ensuring the GxP area(s) under respective Quality unit responsibility are run in accordance with external regulations.
- Ensure conduct of adequate training in the related GxP activities by defining, planning, and supporting training activities.
- Support GxP self-assessments in the corresponding GxP area.
- Manage external inspections, complaints, deviations, recalls, counterfeits, and product security according to the Company’s Quality Policies and Standards.
- Ensure relevant CAPAs have been completed / closed.
- Establishing improvement priorities.
- Ensure quality oversight of third party and coordinate all required activities to guarantee that third party (re)packaging, (re)labelling, storage and/or distribution of Company products is in compliance with Company Standards.
- Establishing and maintaining business continuity plans in the corresponding GxP area.

**INTERESTED APPLICANTS**:
Principal Consultant: Cheong Yee Yin

Registration Number: R22108633

EA License Number: 17C8502


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