Define and plan validation activities to meet the cGMP requirements, coordinate with end users and process owners to develop and execute validation protocols for manufacturing facilities, systems, process and/or software; analyze validation related issues, implement validation related event, Change Control and CAPA.
Key Roles and Responsibilities
- Define and plan validation activities to meet the cGMP requirements
- Coordinate with end users and process owners to develop and execute validation protocols for manufacturing facilities, systems, process and / or software
- Ensure validation activities are completed timely. Analyze validation related issues, implement validation related event, Change Control and CAPA
- Analyze validation results statistically and write reports summarizing results
- Participate in new project initiation, planning, execution and controlling
- Perform other related duties within scope of the department.
Qualification and Experience
- Higher Diploma, Associate Degree or Degree holder in Science, Pharmaceutical, Engineering, or related discipline
- Good interpersonal and teamwork skills, hard-working, willing to learn
- Good language skills in both written and spoken English and Cantonese
- Candidates with less experience will be considered as Assistant Q.A. Validation Officer/Engineer
- Relevant work experience is preferred but not essential
- Fresh graduates are welcome