Salary: $4000 – 6000/ month
Working Hours: Mon – Fri Office Hours (9am – 6pm)
Job Scope:
- Visit the area where the incident has been detected (if applicable
- Discuss with all involved in the incident to gain a full understanding of the process and incident per GQA.003
- Gather background information (or coordinate accordingly) regarding the reported incident
- Perform an initial impact assessment in a timely manner. Identify immediate action to be taken in order to ‘ring-fence’ the problem and ensure it is not further exacerbated whilst the investigation is ongoing.
- Liaise with personnel within various departments / sites and encourage individuals to be forthcoming with pertinent information to facilitate the investigation.
- Host internal meetings (locally or globally, as applicable) and co-ordinate brain-storming sessions to advance the investigation.
- Use appropriate Root Cause Analysis tools (as applicable) to establish causes and any contributory factors.
- Determine the communication strategy and effectively liaise with the PL /PM (as applicable) and all other relevant parties to appraise them of the investigation as it progresses (where applicable). This may extend to include notification of customers, VPs, Key Account sponsors, BD, Commercial Contracts, Quality Management and the QPs (as applicable).
- Escalate to department manager and Quality management any critical issues that become apparent during the course of the investigation that may not have been immediately obvious.
- Document the investigation in the appropriate template. Ensure the report is written to a high standard and that every effort is made to ensure it is Right First Time and acceptable to the customer and the regulators.
- Perform CAPA effectiveness checks as required in a timely manner and provide the necessary evidence of such to Quality.
- Host or participate (as applicable) in external teleconferences / meetings / regulatory inspections to discuss particular incidents, should additional explanation or assurance be needed. Ensure all such contact, oral and written, is carried out professionally in order to develop and maintain good relationships.
- Promote good inter-departmental and global relationships. Work within and across functions and sites as necessary to assure global consideration of investigations and the CAPA arising from such.
- Attend all necessary training and retain a thorough knowledge of processes / procedures pertinent to the area you represent.
- Update KPIs and capture trending information at a department level, ensuring there is good visibility of this data globally. Remain observant of recurring issues, taking such into consideration at the point of an investigation and escalate to management as applicable.
- Meet regularly with management to discuss KPI and trending data. Present ideas / suggestions for consideration into further process improvements.
- Attend periodic meetings with other Lead Investigators locally and globally. Be forthcoming with ideas / experiences to ensure shared learning and continuous improvement.
- Ensure documentation is generated and completed in accordance with the principles of GMP and internal SOPs.
- Fulfil any necessary duties associated with the role, as and when required.
Job Requirements:
- Quality background with focus on report generation and reviews
- Min. 2-3 years relevant experience in quality management
For interested applicants, please send your updated resume to: [email protected]
All candidates’ information will be treated with the strictest confidence
Melissa Zhang Zhiqi (Mezzo)
R2197564
Recruit Express Pte Ltd
99C4599
