Senior Supervisor, Validation

Duopharma Biotech Bhd Group of Companies.; Bandar Baru Bangi; On-site; MYR 100,000 - 150,000; Full time

Job summary

A leading pharmaceutical company in Selangor, Malaysia is looking for an NQAC Lab Technician Grade 2 (Chemistry Lab) to perform qualification and validation activities. The ideal candidate should have a degree in Science and at least 3 years of experience in the pharmaceutical industry. Hands-on experience with lab instruments and proficiency in MS Office are essential. This role ensures compliance with GMP and GLP practices.

Qualifications

• Degree in Science required.
• At least 3 years of experience in the Pharmaceutical Industry.
• Experience in Computer Validation is essential.

Responsibilities

• Execute qualification and validation activities as per Validation Master Plan.
• Assist in coordination with departments for Computer System Validation.
• Participate in regulatory bodies audits and follow up on CAPA needs.

Skills

Analytical skills

Interpersonal skills

Communication skills

Proficiency in MS Office

Education

Degree in Science

Tools

HPLC

UV

Dissolution

Job description

Position Title

NQAC Lab Technician Grade 2 (Chemistry Lab)

Responsibilities

• Responsible for the execution of qualification and validation activities as per Validation Master Plan in accordance to regulatory requirements and company profile.
• To assist in the co-ordination with TS, QC, QA, IT departments etc for adherence, execution and completion of the Computer System Validation.
• To participate in Regulatory bodies audit (i.e NPRA audit, ISO audit) and follow up the corrective action and preventive action (CAPA) needs.
• To execute the MS Excel Spreadsheet for validation.
• To maintain the CV gap assessment for all equipment and system.
• To liaise with vendors regarding equipment calibration and repairs.
• To ensure GMP and GLP practices are strictly adhered to at all time.

Requirements

• Degree in Science.
• At least 3 years of working experience in Pharmaceutical Industry.
• Experience in Computer Validation..
• Hands on experience in operating lab instruments (HPLC, UV, Dissolution, etc).
• Proficient in MS Office application.
• Strong analytical, interpersonal and communication (written & verbal) skills.