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

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