Job Description

Client: Focus is on healthcare and pharmaceutical products

Job Summary: Working with the regional QA organization to provide support in various areas, like technical transfer and FLQR, and other duties as assigned, like affiliate quality support, document management, training, metrics and management review ensuring compliance with regulations and Abbott Quality System requirements

Job Scope:
Technical QA

• Support the execution of quality-related activities in NPI processes including technology transfers & GeoEx and clinical studies.
• Support the participation of QRM pertaining to different NPIs categories & report the QRM performance metrics.
• Implements the quality strategy for the PLCM including product development and monitor the quality performances throughout PLCM.
• Managing product and process quality and compliance throughout the life cycle from development, clinical studies to commercialization.
• Implements the quality strategy for the PLCM including product development and monitor the quality performances throughout PLCM.

Affiliate QA

• Support CDQA regional team

TPM Third Party Manufacturing QA

• Support TPMQ regional team

Management review

• Collating and updating metrics and data for monthly management review elevation to Region & also for facilitating/running the monthly/quarterly Management Review meeting.
• Interfaces with several multi-functional areas, such as Commercial, Distribution, TPM QA Operations, etc. to document, review, and resolve metric performance reporting issues.

Training

• Create training materials and deliver training as requested. Maintain training matrixes for assigned staff.
• Interacts with Corporate Functions and represents APAC and China on corporate initiatives related to training, Metrics and Management Reviews.
• ISOTRAIN system administration and support

Documentation management

• Support coordination and review of new and revised procedures.
• Support coordination and execution of impact review post approval and post obsolescence of procedures.
• Create training materials and deliver training as requested.
• DARIUS system administration and support

eQMS management

• Create training materials and deliver training as requested.
• Interacts with Corporate Functions and represents APAC and China on corporate initiatives related to SoltraQ management and use.
• SoltraQ system administration and support

Regional procedures

• Regional procedure and guideline drafting and implementation

General compliance support

• Support and provide capability-building support to APAC and China sites, TPMQ and affiliates.
• Take ownership to continuously simplify processes

Quality Audit

• Support activities related to onsite GxP audit for APAC and China Suppliers and Third party Manufacturers including Affiliates in line with divisional and regional SOP requirements.

Execute projects and tasks as assigned

• Support Quality program and projects in APAC and China regions.
• Participates in program reviews and provide appropriate recommendations to ensure Quality requirements are met and within established QA processes.
• Prioritizes deliverables and manages project scope and End-to-end QA delivery across teams/sites

Requirements:

• Bachelor Degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering or other technical/scientific area
• 8+ years in a Pharmaceutical industry
• Knowledge of relevant regulations for quality systems and compliance.
• Manufacturing or Quality related experience in some of the following areas: sterile, liquid, solids or API\'s.
• Capable of understanding and overcoming different cultural and other obstacles to provide solutions that satisfy corporate, regional, and local objectives.
• Must be able to effectively deal with problems and internal customers.
• Proficient with Microsoft Office Suite (intermediate MS Excel knowledge required), Adobe Acrobat, Visio, MS Access. System experience is good to have using Trackwise, iQ, Isotrain, and general IT system data entry and report generation desired.
• Good understanding of SOPs, GMPs and quality systems (e.g. ISO, Auditing).
• Understanding of cultural practices and cultural expectations within relevant markets in the region is necessary. To have worked in a multicultural environment is highly desirable.
• Good in collaboration skills, communication skills, problem solving competence & organizational skills.

Additional Information:

• Contract duration: 24-month contract
• Commencement Date: Immediate
• Working days and hours: Mon to Friday, 9am to 6pm
• Location: Bugis, DUO Tower

Lyn, Yee Chen Fu EA License No. 02C3423 Personnel Registration No. R1110796

Please note that your response to this advertisement and communications with us pursuant to this advertisement will constitute informed consent to the collection, use and/or disclosure of personal data by ManpowerGroup Singapore for the purpose of carrying out its business, in compliance with the relevant provisions of the Personal Data Protection Act 2012. To learn more about ManpowerGroup\'s Global Privacy Policy, please visit https://www.manpower.com.sg/privacy-policy

Manpower