Senior Executive - Assistant Manager – QA/QC

Biocon Biologics; Gelang Patah; On-site; MYR 100,000 - 150,000; Full time

Job summary

A leading biopharmaceutical company located in Johor, Malaysia is seeking a QA/QC Specialist with 5–8 years of experience in regulated pharma environments. Responsibilities include managing QA/QC documentation, ensuring compliance with cGMP standards, and developing SOPs. The ideal candidate will have a strong knowledge of regulatory compliance, along with hands-on experience with various LIMS systems. A Bachelor’s degree in Biotechnology or a related field is required, with a Master’s preferred.

Qualifications

• 5–8 years in QA/QC within regulated pharma/biopharma environments.
• Strong knowledge of QMS, ICH and regulatory compliance.
• Experience with data integrity in documentation.

Responsibilities

• Manage QA/QC documentation and ensure compliance with cGMP.
• Develop, review, and approve SOPs for QA and QC.
• Coordinate with cross-functional teams and support audits.
• Review stability protocols and QC data for regulatory filings.
• Support computer system validation and change control processes.

Skills

Knowledge of cGMP

Expertise in QA/QC documentation

Hands-on experience with Novatek LIMS

Hands-on experience with LabWare LIMS

Hands-on experience with TrackWise

Hands-on experience with Veeva

Education

Bachelor's in Biotechnology

Bachelor's in Biochemistry

Master’s in related field

Job description

Job Responsibilities:

Experience: 5–8 years in QA/QC within regulated pharma/biopharma environments

Key Responsibilities:

• Manage QA/QC documentation and ensure compliance with cGMP and data integrity.
• Develop, review, and approve SOPs for QA and QC (Analytical & Microbiological).
• Coordinate with cross-functional teams and support audits (internal/external).
• Review stability protocols, method validation reports, and QC data for regulatory filings.
• Support computer system validation, equipment qualification, and change control processes.

Skills & Competencies:

• Strong knowledge of cGMP, QMS, ICH and regulatory compliance.
• Expertise in QA/QC documentation and data integrity.
• Hands‑on experience with Novatek LIMS, LabWare LIMS, TrackWise, and Veeva.

Education:

Bachelor’s in Biotechnology, Biochemistry, or related field (Master’s preferred).