The Quality Control Officer’s key role is to ensure BCT products meet Pharmaceutical Inspection Co-operation Scheme Good Manufacturing Practices (PIC/S GMP) standards and/or local country specific regulations and BCT manufacture specification standards through providing the highest quality analytical supports and ensure testing is executed in a timely and compliant manner. In addition, this role will own and review quality records, processes and documents, including method development, method validation, corrective and preventive action (CAPAs), change controls and SOPs under the supervision of the RSA Director.
Conduct work activities to ensure finished product (include packaging), immediate, raw material and APIs compliance with BCT’s manufacture specification and PIC/S GMP standards:
Incoming materials are examined and tested to make sure they meet the appropriate specifications
Partially completed products are analyzed to determine their quality and production processes are functioning properly
Finished goods are studied to determine if they meet the specifications for release and customer expectations
Oversee QC testing, method validation, equipment and data systems compliance with PIC/S GMP and/or country specific cGMP standards or ICH compliance
Create, revise, review and approve protocols, supporting analytical data, and reports associated with method validation, testing, and release of GMP starting materials, intermediates, and APIs
Review and approve Certificate of Analysis, Certificate of Test, and stability studies
Serve as QC lead on analytical projects teams and product operational teams
Support IND filing/amendments
Conduct training on QC job related functions and technical methods
Ensure retention samples and testing samples are kept according to regulatory requirements including retain enough for full testing in duplicate
Collaborate with QA Manager to review and investigate all laboratory data outside of range, product complaint and quality failed to meet BCT’s specifications
Perform other duties as may be required or necessary
Manage outsourced testing activities as needed
WORKING CONDITIONS AND ENVIRONMENT:
Normal business environment.
Occasional travel for manufacturing, training and third party monitoring
SKILLS AND QUALIFICATIONS:
BSc or MSc in Chemistry, Pharmaceutical Sciences, Life Sciences or equivalent with 1-2 years experience in the pharmaceutical manufacturing environment or equivalent relevant experience in QC
Preference will be given to candidate with technical proficiency in analytical methodology adherence to PIC/S GMP and ICH compliance
Experience in analytical method development, analytical method validation, and statistical quality control is a plus
Excellent verbal and written communication skills, experience with scientific technical writing including authoring and revising SOP's or technical reports
Able to interact, cooperate, and motivate across departments and functions
Work in a fast paced pharmaceutical environment, able to work flexible schedules on a short notice
We offer 5 days work (9:00am to 6:00pm) week with attractive remuneration package, including Medical Insurance and Transportation allowance. Working location: Hong Kong Science Park. Interested parties please email full resume with expected salary by clicking Apply Now
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Bio-Cancer Treatment International Limited – we are a leading Hong Kong based drug development company specializing in the research, development and marketing of novel therapeutics and their related supporting products for the treatment of human malignancies. To cope with our expansion, we are looking for candidate(s) to take up the below position(s).