日期: 2022 年 5 月 10 日

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

Support timely compilation and submission of dossiers for approval of product registration, change of particulars and renewal, communicate with Support timely compilation and submission of dossiers for approval of product registration, change of particulars and renewal, communicate with Department of Health and respond to their queries, provide regulatory support to internal departments.

Key Roles and Responsibilities

• Support timely compilation and submission of dossiers for approval of product registration, change of particulars and renewal
• Communicate with Department of Health and respond to their queries
• Provide regulatory support to internal departments
• Assist in ad-hoc projects assigned by Q.A Manager

 Qualification and Experience

• Higher Diploma, Associate Degree or Degree holder in science, pharmacy, pharmaceutical or related disciplines
• With good communication skills, hard-working, willing to learn
• Good communication skills in both written and spoken English and Cantonese
• Relevant work experience is preferred but not essential

Fresh graduates are welcome 

Sampling and testing of raw materials, packaging materials, purified water, in-process samples, finished products and stability studies samples, operation of laboratory equipment, assisting in laboratory equipment calibration, qualification and maintenance.

Key Roles and Responsibilities

• Sampling and testing of raw materials, packaging materials, purified water, in-process samples, finished products and stability studies samples
• Operation of laboratory equipment
• Assist in laboratory equipment calibration, qualification and maintenance
• To perform any quality control duties as assigned

Qualification and Experience

• Higher Diploma, Associate Degree or Degree holder in Biology, Chemistry, Pharmaceutical Studies or any related discipline
• Hand-on experience in HPLC, ICP, GC, IR or UV is a definite advantage
• Good team player, self-motivated and fast learner
• Good attitude, hardworking and able to work under pressure
• Minimum 1 year working experience in Pharmaceutical company, chemical laboratory or commercial laboratory
• More experience will be considered as Senior QC Technician
• Less experience will be considered as Assistant QC Technician

Fresh graduates are welcome to apply

Prepare and revise QC SOP and GMP documents, assist in implementing and maintaining the documentation system, prepare validation and qualification documents, conduct product quality review, develop QC training program.

Key Roles and Responsibilities

• Prepare and revise QC SOP and GMP documents
• Assist in implementing and maintaining the documentation system
• Assist in preparing the validation and qualification documents
• Responsible for QC training program
• Responsible for Product Quality Review
• Responsible for Report / Logbook checking
• Prepare QC purchase order and inventory control record
• Provide clerical and administrative support
• To perform any duties as assigned

Qualification and Experience

• Higher Diploma, Associate Degree or Degree holder in Biology, Chemistry, General Science or related discipline
• Good team player, self-motivated and fast learner
• Good attitude, hardworking and able to work under pressure
• Good PC Skills including MS Words, Excel and Chinese word-processing
• Less experience will be considered as Assistant QC Officer
• Fresh graduate will also be considered

PPerform clerical duties and provide general administrative support, prepare purchase order and inventory control record.

Key Roles and Responsibilities

• Perform clerical duties
• Provide general administrative support
• Prepare purchase order and inventory control record
• Perform any duties as assigned

Qualification and Experience

• F.5 or above, with science discipline is an advantage
• Good team player, good attitude, hardworking, self-motivated and fast learner
• Good PC Skills including MS Words, Excel and Chinese word-processing
• Minimum 1 year working experience

Operate all quality related activities in Good Manufacturing Practice ensuring safety and quality of drug manufactured, review process control plan, track drug quality performance, assist drug regulatory registration in Hong Kong and overseas.

Key Roles and Responsibilities

• Operate all quality related activities in Good Manufacturing Practice ensuring safety and quality of drug manufactured
• Review process control plan, drive quality issues to root cause, corrective and preventive actions, track drug quality performance etc.
• Assist drug regulatory registration in Hong Kong and overseas
• Perform ad-hoc tasks as assigned by Supervisor

 Qualification and Experience

• Higher Diploma, Associate Degree or Degree holder in science, pharmacy, pharmaceutical or engineering related discipline
• Fresh graduates are welcomed
• Successful candidate is provided great opportunity to join the challenging and rewarding drug manufacturing industry especially during the COVID pandemic
• Possess good communication skill, willingness to learn, attention to details and hardworking attitude
• No experience required but good communication skill, good command of written and spoken English and Chinese are essential

Supervise day-to-day running of QC laboratory, including daily testing, monitoring laboratory operations and test turnaround time, performing test methods development and validation.

Key Roles and Responsibilities

• Supervise day-to-day running of QC laboratory
• Supervise daily testing, monitor laboratory operations and test turnaround time
• Supervise and train QC staff
• Perform test method development and validation
• Prepare and revise SOP and other relevant quality control documents

Qualification and Experience

• Higher Diploma or Degree holder in Chemistry, Analytical Chemistry, Biology, Pharmaceutical Studies or related discipline
• Familiar with analytical instruments such as HPLC, UPLC, GC, ICP and IR
• 3 years working experience or above in Pharmaceutical company or commercial  testing laboratory and 2 year experience at supervisory level
• Initiative, organized, hard-working, strong leadership and problem solving skills
• Less experience will be considered as Senior QC Technician

Perform sampling of purified water and finished products, assist in the microbiology laboratory operation, prepare test report and assist in quality control operations.

Key Roles and Responsibilities

• Perform sampling of Purified Water and Finished Products
• Involve in Environmental Monitoring Program
• Assist in the microbiology laboratory operation
• Preparing Test Report and involve in all quality control activities 

Qualification and Experience

• Higher Diploma or Degree holder in Biology, food science or Microbiology related subject
• Sound knowledge in microbial test
• Hardworking, initiative, self-motivated and fast learner
• Able to work under pressure
• Good interpersonal skill and communication skill
• Fresh graduates are welcome to apply