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).
Quality Assurance Manager (QAM)
jobsDB Ref. JHK100003004832200
The Quality Assurance Manager’s key role is to ensure BCT products are manufactured and released according to Pharmaceutical Inspection Co-operation Scheme Good Manufacturing Practices (PIC/S GMP) standards and/or local country specific regulations and BCT Standard Operating Procedures (SOPs). The QAM also responsible for the timely release of manufactured product batches according clinical trial schedule and ensuring that quality product is available to patients.
*Ensure all BCT products are manufactured in compliance with PIC/S GMP and BCT’s SOPs and quality standards:
- Appropriate manufacturing in-process controls are implemented;
- In-process controls are performed during manufacturing operations and results are satisfactory, which include ensuring the procedures and specifications of firm are followed under contract, i.e., maintain control and take responsibility for third-party services providers (contract manufacturers, contract laboratories, etc.); and
- The Quality Control (QC) functions are working properly
*Conduct annual internal audits and inspection, including:
- Annual product reviews and review of stability reports for compliance;
- Development, periodic review, revision and implementation of SOPs as required; and
- Self-inspection that procedures and specifications are appropriate and followed
* Host inspectors and coordinate site visits from various regulatory bodies such as FDA, cGMP, etc.
* Train QC for SOP compliance and periodic GMP training for relevant staff as necessary
*Oversee the maintenance and renewals of Drug Establishment License(s)
*Coordinate launch shipments according to BCT contract
*Implementing recall procedures if necessary
*Handle of product complaints
*Conduct investigation of nonconformance:
- Ensure investigation is conducted and root cause is eliminated for production and control record errors, discrepancies, and failure to meet specification, including quality attributes;
- Review complaints to determine if it relates to a failure to meet specification, if so investigate and report to Management if it is serious and unexpected
*To keep management informed on:
- Product, process and system risks
- Outcome of regulatory inspections and ensure responses are complete and managed to verifiable closure
*Manage outsourced activities and consultants as needed •
*Execute other duties as may be required by the Director RSA
WORKING CONDITIONS AND ENVIRONMENT: •
*Normal business environment. •
*Occasional travel for manufacturing, training and third party inspections
SKILLS AND QUALIFICATIONS:
*BSc or MSc in Pharmaceutical Sciences, Life Sciences or equivalent
*5 plus years QA management or relevant experience in the pharmaceutical manufacturing environment including Quality Assurance, Quality Control, and/or Drug Regulatory Affairs
*Experience with GMP inspections and third party audits a plus
*Understanding of pharmaceutical manufacturing laboratory work (including familiarity with various analytical techniques) a strong asset
*Detail oriented person
*Solid decision making skills
*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
*Solid computer skills, using MS Office, MS-WORD and Project Management Software.
*Work in a fast paced pharmaceutical environment, able to work flexible schedules on a short notice
To apply online please click the 'Apply Now' button. For a private and confidential discussion please call Sidney Ng on +852 2521 1566 . Due to the high volume of submittals, only candidates whose skills and qualifications most closely suit our requirements will be contacted.