Senior QC Executive (Stability Study)

Job Responsibilities:

• Authorize and ensure that the stability is tested, and results reviewed and approved in timely fashion in accordance to stability program.
• Review and approve technical reports, test methods and procedural documents.
• Generate and review stability reports.
• Assist to provide problem solving skills to ensure the resolution and documentation of investigations for laboratory and/or manufacturing issues.
• Participate in root cause analysis of non-conformance and recommends corrective action. Ensures timely closure of investigations.
• Performs instrument/method troubleshooting within analytical method parameters.
• Writes, revises, reviews, and implements technical documentations which may include protocols, reports, analytical test procedures; and change controls, whenever necessary.
• Initiate change control documentation and reports, deviations, OOS, OOT and other manufacturing and laboratory investigations and initiates and coordinate corrective and preventive actions as required, related to stability study stage.
• Establish continuous improvement of QC activities through regular reviewing of SOPs, test protocols & specifications, including:
• Interfacing with colleagues to ensure effective corrective and preventive actions are implemented for any recurring product/process discrepancies.
• Reviewing internal SOPs/policies to align with industry standards related to analytical method and reagent lifecycle.
• Improving GMP compliance and documentation.
• Maintain systems to track and trend key Quality Indicators and develop appropriate KPIs.
• Oversee and monitor the QC laboratory (in partnership with other QC staff) to ensure that all QC-related activities and equipment operations are conducted with foremost consideration for safety and in compliance with GLP, by ensuring proper upkeep and maintenance of all laboratory equipment.
• Ensure GMP regulations, corporate Taisho policies and company Standard Operating Procedures (SOPs), and ensure that all relevant SOPs are revised and updated in accordance to stipulated intervals.
• Determine and maintain effective operations through proper budgeting and planning of QC activities/expenses.
  • Ensure that QC staff (Stability team) are adequately and appropriately trained and are able to demonstrate capability in job tasks. Initiate technical development training and empowering of first line supervisors and holding them accountable for activities required to meet deadlines.
  • Conduct timely and proper training & development, motivation and performance appraisal process for QC personnel, in line with Company HR policies to maintain a well-trained & highly skilled QC workforce.
• Support product registration (local & overseas) through compilation and submission of stability study reports to Regulatory Affairs Department.
• Foster an atmosphere of teamwork, commitment and dedication towards quality and continuous improvement.
• Record, track, and maintain relevant data and present progress to upper management in a timely manner through weekly/monthly and ad-hoc reports.
• Participate actively in activities involving QC department, including the following:]
  • Self-inspection/Self-Audit programs organized by QA department.
• 5S and Health, Safety & Environment (HSE) activities.
• Embraces a "team" working environment focused on achieving department goals by demonstrating willingness to accept assignments not specifically listed above as allowed by the limitations of training, experience, and/or education.

Job Requirement

• Bachelor of Science (Applied Chemistry) with Honors or equivalent discipline
• A strong technical background, and proven track record in Quality Control.
• Minimum 4-5 years working experience in manufacturing of pharmaceutical/OTC/cosmetic/healthcare-related industry preferred.
• The ideal candidate will have a proven track record in a pharmaceutical/OTC/cosmetic/healthcare-related product manufacturing facility.
• Proficient knowledge on quality control systems & equipment like HPLC, GC, FTIR and UV spectrophotometer.
• Proficient knowledge in analytical testing of drug substances and formulations, and of computer systems for sample tracking, laboratory equipment, raw data handling and storage.
• Adequate problem solving and analytical skills with demonstrated ability to manage several investigations.
• Ability to effectively plan and organize work activities and prioritize task completion to adhere to schedules and deadlines in stability program.
• Ability to work with multi-departmental team and personnel at various levels in the facility.
• Excellent supervisory skills with the ability to coach and mentor staff in order to develop skills and competencies required to meet business needs.
• Strong interpersonal and communication skills: oral/written and listening.
• Pharmaceutical GMP knowledge.
• Proficiency in Microsoft Office programs.

• Behavioral Competencies: