Location: Glenmarie, Selangor
Company: Duopharma HAPI Sdn. Bhd.
Job Summary
This role is responsible for executing validation and qualification activities in accordance with the Validation Master Plan to ensure compliance with NPRA requirements, cGMP standards, and industry regulations. The successful candidate will support process validation, equipment qualification, cleaning validation, computer system validation, and technology transfer activities to ensure consistent product quality and regulatory compliance.
Key Responsibilities
Validation & Qualification Activities
- Execute validation activities including process validation, performance qualification, cleaning validation, computer system validation, and temperature mapping studies
- Perform periodic re-evaluations and requalification activities as required under the Validation Master Plan
- Support qualification and validation of critical manufacturing processes and systems
Documentation & Compliance
- Prepare, review, and maintain validation protocols, reports, and supporting documentation in accordance with Good Documentation Practice (GDP)
- Verify validation-related spreadsheets, records, and technical data
- Ensure validation documentation is properly maintained and readily available for audits and inspections
Cross-Functional Coordination
- Collaborate with Quality Control, Engineering, Production, and Quality Assurance teams to execute validation activities successfully
- Coordinate validation schedules and ensure completion of assigned validation projects within timelines
- Support regulatory submissions and product registration activities where validation input is required
Technology Transfer & Continuous Improvement
- Participate in technology transfer activities for new products and processes
- Identify opportunities to improve validation systems, processes, and documentation practices
- Stay updated on regulatory expectations and industry best practices related to validation
Business Continuity & Departmental Support
- Support business continuity by managing assigned validation activities and documentation
- Assume delegated responsibilities during the absence of key validation personnel when required
- Perform other duties assigned by management in support of departmental objectives
Requirements
Qualifications
- Bachelor's Degree in Chemical Engineering or related engineering discipline
Experience
- Minimum 6 years of experience in the pharmaceutical industry
- Hands-on experience in validation, qualification, or compliance-related activities is preferred
Technical Skills & Knowledge
- Strong knowledge of process validation, performance qualification, and cleaning validation
- Familiarity with cGMP requirements and pharmaceutical regulatory expectations
- Understanding of validation lifecycle management and documentation requirements
- Proficient in Microsoft Office applications, particularly Excel, Word, and PowerPoint
- Strong technical writing and report preparation skills
Competencies
- Strong analytical and problem-solving abilities
- Effective communication and stakeholder management skills
- Detail-oriented with a strong compliance mindset
- Self-motivated and capable of working independently
- Results-driven with the ability to manage multiple priorities
Why Join Us
- Exposure to end-to-end validation and qualification activities
- Opportunity to work in a regulated pharmaceutical manufacturing environment
- Involvement in technology transfer and continuous improvement initiatives
- Career development opportunities within quality and compliance functions
- Collaborative working environment with cross-functional exposure
