Associate Manager, QA Validation & Qualification

Biocon; Gelang Patah; On-site; MYR 180,000 - 240,000; Full time

Job summary

Biocon is seeking a Lead QA professional to oversee qualification and validation activities across equipment, facilities, and computerized systems.

You will review and approve IQ/OQ/PQ documents, ensure compliance with cGMP, GDP, and regulatory requirements, and support audits with robust validation records. The role demands strong QA leadership in a GMP biotech environment.

Qualifications

• Experience in QA validation within GMP-regulated environments.
• Knowledge of qualification and validation lifecycle documents.
• Familiarity with cGMP, EU GMP, FDA and data integrity principles.
• Degree in a related discipline is required.

Responsibilities

• Lead QA oversight for qualification and validation activities.
• Review/approve IQ, OQ, PQ protocols and reports.
• Ensure activities comply with cGMP, GDP, GEP and regulatory requirements.
• Provide QA support for equipment introduction, facility upgrades and tech transfers.
• Review Change Controls, Deviations, CAPAs and risk assessments related to validation.
• Support audits with validation and qualification documentation.
• Drive continuous improvement and standardization of validation processes.
• Ensure timely closure of validation quality records and inspection readiness.

Skills

QA Validation

Validation Lifecycle

Quality Systems

Data Integrity

Regulatory Compliance

Education

Degree in Pharmacy/Biotech/Engineering/Life Sciences

Job description

• Lead QA oversight for qualification and validation activities covering equipment, utilities, facilities, and computerized systems.
• Review and approve qualification and validation lifecycle documents, including URS, Risk Assessments, IQ, OQ, PQ protocols, reports, and validation master plans.
• Ensure commissioning, qualification, and validation activities are executed in compliance with cGMP, GDP, GEP, and regulatory requirements.
• Provide QA support for new equipment introduction, facility upgrades, technology transfers, and expansion projects.
• Review and approve Change Controls, Deviations, CAPAs, and Risk Assessments related to validation and qualification activities.
• Perform quality oversight during critical qualification and validation activities to ensure compliance and data integrity.
• Support regulatory audits, customer audits, and inspections by providing validation and qualification documentation.
• Drive continuous improvement initiatives and standardization of validation and qualification processes.
• Ensure timely closure of validation-related quality records and maintain inspection readiness at all times.

Requirements:

• Degree in Pharmacy, Biotechnology, Engineering, Life Sciences, or related discipline.
• Experience in QA Validation, Qualification, Commissioning, or Quality Systems within a GMP-regulated pharmaceutical/biotechnology environment.
• Strong knowledge of Equipment Qualification, CSV, Cleaning Validation, Process Validation, Change Control, CAPA, and Risk Management.
• Familiarity with regulatory requirements including cGMP, EU GMP, FDA, and Data Integrity principles.