職位描述
Job description:
1.To commit the professional QA support in BM supply point regarding compliance and quality issues
？ Develop and implement consistent processes and systems that assure quality, GMP, and compliance
？ Promote the continuous development of Quality Assurance of AZBM OSD production line
？Communicate with other AZ sites regarding to quality issues
2. Quality systems management
？ Ensure OSD QA review and approval of GMP documentation that has direct impact on the activities, equipment and facilities. This includes
-Change requests
-CAPA
-Quality investigations arising from deviations and product complaints
-Validation plans, protocols and reports
-Product disposition
-SOP
3. GMP compliance
？ Ensure compliance with all GMP and regulatory requirements
-All internal audit and regulatory agency inspection queries are supported and addressed.
？ Ensure GMP compliance during the planning, execution and closeout phases of capital and non-capital improvement projects that support related activity.
？ Provide related training and ensure maintain GMP awareness of AZBM staff
4. Review production sheet and release product
？ Batch record review
？ Make OSD product & material release decisions
5. Quality Risk Management requirements
？ Establish and maintain quality risk management system based on GMP requirements
？ Supervise effective execution of quality risk management
？ Provide quality risk management support, suggestion and training to other functions
6. Lead the management of OSD QA affairs
？ Ensure to fulfill the KPIs of QA
？ Quality continuous improvement
？ Returned goods handling
？ Complaint management
？ Annual product review
7. Supervisory responsibilities
？ Responsible for OSD QA team daily management
-Lead daily job in OSD QA team
-Work instruction and training to subordinate
-Build and develop team capability
-Provide daily performance feedback to staff
-Conduct formal performance evaluations to staff
8. Stakeholder Focus
OSD Production, Engineering & SHE , Supply Chain, Technical Service, OSD warehouse, CMO team
9. SHE responsibilities
-Maintaining a safe and healthy workplace and identifying、understanding、controlling and mitigating the specific SHE risks and requirements for your particular staff and teams.
-Maintaining a reliable process for setting up, delegating responsibility for, and reviewing the effectiveness of risk-management decisions and controls.
-Making sure staff understand the full range of their SHE responsibilities and are trained against identified needs to perform their jobs safely, in a way that protects the environment and otherwise in line with AZ requirements and applicable laws, regulations and local procedures.
-Making sure that visitors understand and follow any relevant local procedures for their own safety.
-Making sure that any accidents, incidents and non-compliance with AZ SHE policy are reported and investigated and that appropriate corrective action is taken.
-Supervising staff, making sure that they take personal responsibility for managing the SHE risks associated with their roles, and that their performance against SHE responsibilities is built into the performance evaluation.
Job Requirements:
？ University graduate, major in pharmaceutical or related subjects
？ Comprehensive knowledge of international GMP requirements, quality systems, and pharmaceutical manufacturing/packaging technologies.
？ Comprehensive knowledge of regulatory agency interactions and compliance procedures, with ability to apply the knowledge in an operations environment
？ Comprehensive understanding of Lean concepts & applications
？ Familiar with new product introduction process.
？ Knowledge of Process control & capability methodology, for example Cpk, FMEA.
？ Ability to effectively balance and manage the challenges created by accelerated finished product delivery schedules and the need to ensure all quality requirements are addressed prior to the release of the finished product to AZ customers.
？ Ten years plus experience within QA in the Pharmaceutical Industry, with at least 5 years supervisory/managerial roles.
？ Good English in writing and speaking
？ Good Computer skill
？ Working knowledge of Microsoft applications, SAP or similar system
