POSITION SUMMARY:
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.

GENERAL RESPONSIBILITIES: 
*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

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