Job Scope:
- Perform the role of Lead Investigator into incidents to which you have been assigned. In doing so, it is necessary to immediately:
- Visit the area where the incident has been detected (if applicable, e.g. if detected internally in an operational setting)
- 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. This may involve Lead Investigators in other areas or at other sites.
- 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.
- Determine appropriate and meaningful CAPA to prevent recurrence. Gain agreement of such with department managers (locally or globally, as applicable).
- 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.
- Proactively monitor the progress of all investigations assigned to you and prioritise accordingly. Take responsibility and ownership for such endeavoring to ensure close out in a timely manner. Escalate any that are overdue.
- 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.
- Endeavor to approach problems with a positive attitude and as an opportunity for company to continuously improve.
- 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.
Requirement
- Has prior QA background with focus on report generation and reviews
- Able to engage multiple stakeholders independently.
- Min. Degree in Science
- Has prior pharma background will be an advantage
If interested, please email your resume to [email protected]
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Alex Goh Hock Leong
(CEI.No: R1763413 l Recruit Express Pte Ltd (Healthcare & Life Science) | 99C4599)
