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Senior Quality Control Specialist
4 weeks ago
Job Summary:
We are seeking a highly organized and detail-oriented Senior QC Analyst to join our team at Piramal Group. As a key member of our Quality Control department, you will be responsible for ensuring the quality and compliance of our products.
Key Responsibilities:
- Execute analytical procedures for testing of raw materials, in-process products, bulk drug substance, final products, and stability products according to defined SOPs and protocols.
- Apply best cGMP work-practices and techniques to test and release raw materials, in-process products, bulk drug substance, final products, and stability products within specification.
- Ensure that all QC analysts are appropriately trained and competent in the procedures they are conducting, and are in compliance with best cGMP working practices at all times.
- Conduct on-time reporting according to defined and trained document management standards, including review and verification of analytical data provided by the QC Analysts.
- Immediately escalate and report any deviations to materials, facilities, processes, or procedures to the QC Manager.
- Be accountable for the analytical laboratories being clean, tidy, and well-organized, and in a state of continuous inspection readiness.
- Conduct all activities in the most careful and safe manner, and in full compliance with ESH requirements.
- Ensure that at any time, equipment, facilities, and materials used in the area of responsibility comply with defined standards.
- Issue, manage, and close-out deviations, change controls, OOS or SST investigations, and CAPAs in a timely fashion.
- Identify areas for continuous improvement and escalate those to the QC Manager.
- Actively contribute to the development and maintenance of an enthusiastic, supportive, and collaborative environment within the team-setting.
- Support installation, qualification, and periodic review of equipment.
- Support the transfer of new methods and techniques into Quality Control.
- To undertake any other duties as requested by the line manager in accordance with company requirements.
Competencies:
- Highly organized
- Effective communication
- Ability to motivate and organize a small team
- Attention to detail
- Understanding of scientific and technical processes
- Problem-solving
- Investigation of deviations