Key Responsibilities
- Manage the storage and inventory of laboratory samples
- Conduct analytical testing and documentation for APIs, drug substances/products, complaints, packaging materials, and stability samples
- Ensure strict compliance with cGxP standards, including data integrity requirements
- Execute and document stability testing (if not centralized), including storage, testing, and reporting to cGxP standards
- Follow all Health, Safety, and Environment (HSE) guidelines
- Identify and report safety risks or potential incidents, and propose preventive solutions
- Participate in mandatory training and retraining programs
- Support operations during rotating day/night shifts
Role Requirements
Essential Qualifications and Experience
- Prior experience in a laboratory setting within the pharmaceutical industry (QA, production), with exposure to aseptic techniques preferred
- Proficiency in administrative and documentation tasks compliant with GMP and HSE standards
- Demonstrated strengths in:
- Breakthrough analysis and problem-solving
- Resilience and adaptability
- Operational efficiency and continuous learning
- Digital fluency and technical skills
Technical Competencies
- Hands-on knowledge of laboratory instruments and QC testing procedures
- Strong command of GxP, TQM principles, and lab excellence standards
- Ability to maintain QC IPC/DS laboratory equipment and systems in accordance with cGMP compliance
- Competent in executing product testing within timelines and contributing to validation and method transfer protocols
- Skilled in performing routine in-process, release, and stability testing, including documentation review
- Capable of supporting lab investigations and leading root cause analysis
- Detail-oriented in preparing and verifying QC documentation to ensure accuracy, consistency, and regulatory compliance
- Proactively identifies opportunities to optimize testing procedures
- Supports audit readiness and participates in internal audits and inspections by health authorities