POSITION SUMMARY:

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. 

GENERAL RESPONSIBILITIES:

• 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. Interested parties please email full resume with expected salary by clicking APPLY NOW