Job Title: Laboratory Operations Manager
This role is accountable for overseeing the overall operation of the laboratory, ensuring compliance with regulatory standards and facilitating product release.
Key Responsibilities:
* Ensure that documentation such as Standard Operating Procedures (SOPs), Certificates of Inspection (COIs), and quality documents are up-to-date and accessible.
* Investigate deviations and implement corrective actions to ensure effective closure of nonconformities.
* Support internal and external audit activities by providing relevant information and expertise.
* Monitor laboratory performance metrics and take proactive measures to address any issues.
* Develop and manage testing schedules for raw materials, in-process samples, finished goods, pilot batches, and validation studies to support timely product release.
Additional Responsibilities:
* Verify data integrity and accuracy to meet quality standards.
* Oversee the stability testing program, including investigation of out-of-specification results and communication with regulatory bodies and clients when necessary.
* Support new product introductions by coordinating required analytical testing according to project plans.
* Lead, develop, and support the Quality Control team to achieve output goals and deadlines.