Job Summary
Execute frontline sterile drug product manufacturing operations, including material management, equipment handling, aseptic operations, process monitoring, visual inspection, packaging and GMP compliance across the entire production workflow, etc.
Responsibilities
Production Execution & Equipment Operations
·Set up and operate pharmaceutical production equipment for sterile drug product manufacturing processes (materials sterilization, formulation, filter integrity testing, vial washing and depyrogenation, filling, lyophilization, capping, external washing, visual inspection, packaging and labelling).
·Strictly follow aseptic techniques and practices during aseptic operations in accordance with relevant SOPs.
·Perform cleaning and upkeep of production equipment and classified manufacturing areas as per relevant SOPs and batch records.
·Review, approve, and close out safety work permits in compliance with site safety procedures.
·Possess mastery of DP equipment principles and familiarity with the production process, enabling independent operation and basic maintenance/ troubleshooting of related equipment.
- Report deviations promptly, assist in deviation investigation and CAPA implementation
- Maintain ALCOA++ compliant documentation by accurately completing batch production records.
·Conduct and support the commissioning, SAT, IQ, OQ, PQ, smoke study, media fill, equipment qualification and validation related work during the facility construction stage.
·Any other duties as and when assigned by the Manager or supervisor.
Material Management & Quality Control
- Manage material handling (issuance, verification, return) with proper status labelling.
· Perform all material and process transactions in SAP at each manufacturing step in accordance with relevant SOPs and batch records.
- Support environmental monitoring (settle plates/airborne particles sampling) and in-process tests sampling
Compliance & Continuous Improvement
- Strictly adhere to SOPs and EHS protocols (cleanroom gowning, sanitization procedures)
·Participate in process optimization trials (e.g., lyophilization cycle adjustment) and propose efficiency improvements
- Support client/regulatory audits through live process demonstrations and document retrieval
·Support the revise of relevant operating procedures, batch production records, and related files in accordance with GMP requirements
Qualifications
·Diploma or higher in Pharmaceutical Manufacturing, Pharmaceutical Engineering, Pharmacy, Bioengineering, Biotechnology, Chemical Engineering, Microbiology, or related fields.
· Fresher or personnel with 1 or 2 years of relevant experiences in pharmaceutical industry.
·Knowledge of GMP is preferred, with expertise in aseptic production being an advantage.
·Possess a solid foundation in pharmacy and biotechnology, with proficiency in Microsoft Office.
·Strong English language skills and the ability to proactively analyze and solve problems that arise in the workplace.
·Excellent hands-on operational skills, with careful and conscientious equipment operation and timely record-keeping.
·Good communication and expression skills.
·Effective team collaboration, efficient execution, and a strong sense of responsibility.
·Flexibility to work on day, afternoon, or night shifts, and on weekends as part of shift rotations, depending on production scheduling needs.
Training Opportunities
·Production Skills Training: Helps you quickly meet the technical qualification requirements for your current position.
·GMP Hands-on Training: Media fill qualification, Grade A isolator behaviour
·Equipment Usage Skills Training: Familiarize yourself with the facilities and equipment involved in DP.
·Vocational Training: Become familiar with the characteristics and mechanisms of various biopharmaceutical R&D and production, master the skills of efficiently and reasonably managing time, and enhance your core competitiveness.
·Safety Awareness and Professional Training: The company offers a comprehensive system of safety training materials and experienced instructors.
·Monthly Academic Reports: World-renowned scientists and experts are invited to deliver lectures.
·Management Skills Training: Provided by company executives and renowned training institutions to improve employees' practical and theoretical knowledge.
