My client a well established Pharma company is looking out for a competent QA Associate, this following are the requirements:
Responsibilities
- Contract/External Manufacturer Quality Oversight: Monitor quality aspects of contract manufacturers, including handling OOS/NCR/Deviation and CAPA, Change Control, and routine stability testing. Ensure compliance with GMP and relevant standards, meeting timelines for actions.
- Releases of products : Oversee batch release to prevent recalls or critical quality issues in the market.
- Change Control: Address individual change controls promptly and efficiently. Manage the change control process, ensuring compliance with GMP and company SOPs. Execute change control tasks within defined timeframes.
- Artwork Review: Conduct artwork reviews to meet requirements.
- Manage deviations, NCR, CAPA: Prevent recalls or critical quality issues related to due diligence.
- Customer Complaints: Collaborate with internal departments and suppliers to oversee the complaints process.
- Document Management:Update SOPs/WIs/FGS as per role responsibilities.
- Internal and External Auditing: Conduct and faciliate resolution audits within specified timeframes, adhering to regulations and SOP and follow up on NCR/CAPA outcomes.
Key Requirements
- Possesses BSc in chemistry, pharmacy, or related field.
- 1 to 3 years of QA experience in pharmaceutical/medical device industry
- Strong familiarity with Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP)
- Experience in supply chain quality, manufacturing quality, or quality management in commercial settings.
- Proficient in deviation management, CAPA, change control, and documentation within pharmaceutical/medical device sectors.
- Auditing experience is desirable.
- High level of attention to details
How to Apply:
Interested applicants may apply by sending in your updated résumé (in MS Word format) to my email or apply directly:
Consultant: Tan Jun Jie
EA personnel reg. no.R1878852
EA License No. 17C8502
