QC Lab Quality Lead – Start-Up & Validation

American Unicorn Laboratories Limited; Sha Tin; On-site; HKD 520,000 - 820,000; Full time

Benefits offered by this job

Five days work week

Medical and dental insurance

Educational sponsorship

Performance bonus

MPF

Job summary

American Unicorn Laboratories Limited is seeking a capable QC Manager to oversee startup activities of the QC lab. You will coordinate equipment qualification, validate test methods, and perform monograph testing on starting materials, ensuring compliance with GMP/PICS and ISO standards.

You will train QC technicians, maintain documentation, and collaborate with QA and Production on process and cleaning validations, with a strong emphasis on accuracy, timeliness, and teamwork in a fast-paced

Qualifications

• Degree or above in Science (Chemistry / Biology / Pharmaceutical Science or related discipline)
• At least 5 years in a commercial testing or pharmaceutical laboratory
• At least 3 years in a supervisory role
• Knowledge of GMP/PICS and ISO standards
• Extensive knowledge in chemistry laboratory work
• Extensive knowledge and experience with HPLC, UV, IR and other analytical instruments
• Strong interpersonal and communication skills
• Willing to work overtime; immediate availability appreciated
• Candidates with less experience may be considered for QC Supervisor

Responsibilities

• Assist Q.C. Manager in monitoring overall activities during startup of the QC lab
• Coordinate and perform equipment qualification and prepare qualification protocols and reports
• Coordinate and perform test method validation
• Coordinate and perform full monograph testing on starting materials
• Collaborate with QA and Production on testing of process validation and cleaning validation samples
• Train QC technicians
• Maintain documentation system in GMP compliance
• Perform ad-hoc duties and other QC-related duties

Skills

Team leadership

Communication

Analytical chemistry

Quality systems

Overtime willingness

Education

Bachelor's degree in Science

Tools

HPLC

UV

IR

Job description

American Unicorn Laboratories Limited is seeking a capable QC Manager to oversee startup activities of the QC lab. You will coordinate equipment qualification, validate test methods, and perform monograph testing on starting materials, ensuring compliance with GMP/PICS and ISO standards.

You will train QC technicians, maintain documentation, and collaborate with QA and Production on process and cleaning validations, with a strong emphasis on accuracy, timeliness, and teamwork in a fast-paced