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Investigation Specialist
2 months ago
The QA Investigation Specialist plays a pivotal role in ensuring the highest standards of quality and compliance within Pharmascience's PMS plants. This position is responsible for conducting thorough investigations into non-conformance reports, deviations, and other quality-related issues. The successful candidate will possess strong analytical skills, with the ability to summarize complex data and identify root causes. Effective communication and collaboration skills are essential, as this role requires interaction with various stakeholders, including production teams, quality assurance personnel, and external partners.
Key Responsibilities:
- Coordinate investigations into raw material, manufacturing, and packaging lot issues, as well as utility and OOS lab results.
- Gather information, conduct root cause analysis, and evaluate patient, product, and systems risks.
- Develop and implement corrective and preventive actions to prevent recurrence.
- Contribute to the generation of trend analysis reports and performance indicator reports.
- Maintain investigation databases and ensure compliance with regulatory requirements.
- Participate in investigation meetings and provide expert QA guidance.
Requirements:
- Strong analytical and problem-solving skills.
- Excellent technical writing and communication skills.
- Ability to work collaboratively in a team environment.
- Proficiency in MS Office and SAP, with certification an asset.
- Knowledge of laboratory and pharmaceutical manufacturing operations.
