YOUR TASKS AND RESPONSIBILITIES:
- Maintain and coordinate QMS at Global Business Services (GBS)
- Perform implementation of global SOPs to QMS
- Based on updates, train staff with respective effectiveness check.
- Lead self-inspection program: Audit Schedule, Documentation, CAPA follow up, control and report metrics related to KPIs.
- Oversee documentation lifecycle, promote GxP in GBS, promote coordinated teamwork to achieve Data Integrity Standards, support QAAs preparation and update.
- Monitor the deviation/CAPA system.
- Challenge and review root cause investigations and CAPA plans by applying risk management techniques (xFMEA).
- Ensure timely implementation and execution of action plans
- Lead the compilation, analysis and reporting of Quality Metrics (including but not limited to Management Review, KPIs, Quality Board) to detect signals and anticipate potential non-conformities.
- Maintain key performance indicators as per quality objectives
- Identify efficiencies and drive improvements as identified.
- Safeguard all documents and confidential information.
- Perform regular cross meetings between GBS sites to ensure common understanding of QMS.
- Promote continuous improvement by identifying problems.
- Development of projects to determinate the fundamental causes of the problems and definition and implementation of action plans.
- Act as approver in documents assigned in LifeDoc and some other quality related documents in paper based as required.
Who You Are
- Bachelor's degree in life-sciences (chemistry, chemical engineering, pharmacist or equivalent)
- Experience in Quality Management systems, GxP and Data Integrity Requirements. Strong knowledge in Statistical Techniques (DOE, SPC).FDA, ISO, euMDR auditing requirements.
- Internal Quality Auditor or CQE certification preferred.
- Project Management methodologies or Green Belt certification (Desirable).
- High-level computer knowledge (Excel, Word, E-mail, Change Control, Power Point, SAP, Project, Visio).
- Extensive and strong problem solving, root-cause analysis and technical/engineering skills to lead and influence change.
- Strong technical writing skills and attention to detail.
- High learning agility and flexibility to adapt to different projects based on business demand.
- Strong leadership, conflict resolution, negotiation and communication skills, leveraging those skills across different cultures and functions.
- Proven ability to work under pressure and willingness to international travel.
- Fluent in English mandatory (native or proficient), any other language beneficial.
Application Period: 11/30/2023 - 12/11/2023
Reference Code: 807887
Division: Enabling Functions
Location: Philippines : National Capital : Taguig
Functional Area: Quality
Position Grade: VS 1.1
Employment Type: Regular
Work Time: 40 Hours
Contact Us
Address Telephone E-Mail
9th Flr. Science Hub Tower 1 Campus Ave. Cor. Turin St.
McKinley Hill Cyberpark, Pinagsama,
Taguig City 1630 +63 2 88580682 [Confidential Information]
