Senior Quality Assurance Specialist
2 days ago
As a Senior QA Associate, Compliance/QA Lead at Granules Consumer Health, you will play a crucial role in ensuring product compliance to established cGMPs, meeting safety and quality standards for FDA Regulatory and customer requirements by adherence to Standard Operating Procedures (SOPs).
Key Responsibilities:
- Conduct assessments of cGMP Compliance gaps and implement plans for gap closure.
- Support Serialization and aggregation process implementation as per the Drug Supply Chain Security Act (DSCSA).
- Interpret and discuss key Quality metrics data to recommend changes required to sustain Quality and safety of manufactured products.
- Review and release of batches, participation in qualification of utilities, systems, and equipment on-site.
- Support training programs to ensure competency of personnel engaged in cGMP activities.
- Support all aspects of investigations, including out-of-specification and manufacturing investigations.
Requirements:
- Bachelor's/master's in chemistry or related scientific field.
- Minimum 5+ years hands-on Quality Assurance experience in Pharmaceutical Industry.
- Experience in OSD Pharmaceutical Packaging Operations required.
- Hands-on experience in implementation of Serialization and aggregation process highly preferred.
- Knowledge of Good Manufacturing Practices (cGMP).
Physical Requirements/Working Environment:
- Laboratory environment with lab coats and safety glasses.
- 8 hours per day.
- 6-8 hours standing while performing the task.
- Must be able to lift 50lbs.
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