IT QA Lead - Pharma/Manufacturing Compliance

Biocon; Gelang Patah; On-site; MYR 75,000 - 100,000; Full time

Job summary

A leading pharmaceutical company in Johor, Malaysia seeks an experienced IT Quality Assurance Specialist to oversee IT activities related to manufacturing systems. The role requires approval of key documentation, support on operating systems, and compliance with quality management systems. Candidates should have at least 5 years of experience in the IT and pharma industry, with expertise in computer systems validation and GxP compliance. Strong verbal communication and negotiation skills are essential.

Qualifications

• 5 years in IT and pharma industry with CS knowledge.
• Experience in Pharmaceutical organization.
• Expertise in implementing 21 CFR Part 11 and GAMP5 guidance.
• Ability to handle Qualifications Re-Qualifications.

Responsibilities

• Approve inventory list of Manufacturing system at Malaysia site.
• Review and approve IT related SOPs.
• Provide QA support on Operating system of computer systems.
• Ensure User Management and data management.
• Approve change control, deviation and CAPA in Trackwise.

Skills

IT and pharma industry experience

Computer Systems Validation expertise

GxP Compliance knowledge

Strong verbal communication skills

Experience in QMS management

Job description

A leading pharmaceutical company in Johor, Malaysia seeks an experienced IT Quality Assurance Specialist to oversee IT activities related to manufacturing systems. The role requires approval of key documentation, support on operating systems, and compliance with quality management systems. Candidates should have at least 5 years of experience in the IT and pharma industry, with expertise in computer systems validation and GxP compliance. Strong verbal communication and negotiation skills are essential.