QA Specialist, API & Manufacturing — cGMP Compliance

NOVEXX PTE. LTD.; Singapore; On-site; SGD 60,000 - 98,000; Full time

Job summary

NOVEXX PTE. LTD. in Tuas, Singapore, is seeking a meticulous Quality Assurance Specialist to uphold cGMP compliance, review batch records, and oversee quality systems for APIs and intermediates.

The role requires strong QA experience in pharmaceutical manufacturing, knowledge of ICH guidelines, and effective cross-functional collaboration with SMEs and internal teams. Suitable for professionals with 4+ years of QA experience (or 1+ year with a relevant bachelor’s degree).

Qualifications

• Diploma in Chemistry, Chemical Engineering, Pharmacy, Life Sciences, or related field with 4+ years QA experience, OR a Bachelor's degree with 1+ year experience.
• Experience in pharmaceutical/API manufacturing and familiarity with QMS.
• Solid knowledge of cGMP standards and ICH guidelines.
• Strong written and verbal communication across interdepartmental teams.

Responsibilities

• Review and approve batch records for APIs and intermediates.
• Review and approve cleaning instructions, SOPs, reports, and change controls.
• Ensure compliance with cGMP and regulatory requirements.
• Review deviations, investigations, RCA, CAPA with SMEs.
• Assist audits and inspection readiness.
• Maintain quality metrics and participate in APR.
• Collaborate with Value Stream Teams to resolve quality issues.
• Support safety initiatives and EHS investigations when required.

Skills

cGMP knowledge

ICH guidelines

Quality Assurance

Communication skills

Education

Diploma in Chemistry / Chemical Engineering / Pharmacy / Life Sciences

Bachelor's degree in a relevant scientific field

Tools

ERP systems

Electronic Quality Management Software

Job description

NOVEXX PTE. LTD. in Tuas, Singapore, is seeking a meticulous Quality Assurance Specialist to uphold cGMP compliance, review batch records, and oversee quality systems for APIs and intermediates.

The role requires strong QA experience in pharmaceutical manufacturing, knowledge of ICH guidelines, and effective cross-functional collaboration with SMEs and internal teams. Suitable for professionals with 4+ years of QA experience (or 1+ year with a relevant bachelor’s degree).