Quality Control Lab Supervisor
Quality Control Lab Supervisor
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Job Description
Job Title:Quality Control Lab Supervisor
Reports To: Quality Manager
Employment Type: Full-time (FTE)
Job Summary:
The QC Lab Supervisor is responsible for managing daily operations of the Quality Control laboratory within the plant that produces cosmeticandOTC drug products including the testing services that are outsourced from the external laboratories. This role ensures all lab activities comply with the applicable standards and regulations including ISO 17025 ISO 22716 MoCRA 21 CFR Parts 210 & 211andUSP Standards. The QC Lab Supervisor ensures that the lab analysts across all 3 shifts deliver timely accurate & cost-effective testing performs on time & conclusive lab investigations ensures data integrity and owns readiness for client audits and regulatory/third party inspections.
Key Responsibilities:
- Lead and co-ordinate daily operations of the QC laboratory including sampling and testing of raw materials packaging components in-process finished products and stability samples for cosmetic and OTC drug products across all 3 shift operations.
- Ensure all test methods are validated and QC Lab operates in compliance with ISO 17025 ISO 22716 MoCRA and 21 CFR Parts 210 & 211 USP and internal specifications.
- Prepare review & approve all the SOPs for QC Lab operations and ensure its effective deployment. Review & approve RM PM FG Specifications in coordination with clients and/or R&D.
- Be responsible for the qualifications of the external laboratories and co-ordinate all the outsourced testing in an efficient (cost and lead time) & compliant manner.
- Supervise and support the team of analysts providing them with the required training technical guidance and performance feedback to build a capable & reliable QC team.
- Review and approve the testing data test reports (COA) and laboratory documentation for accuracy completeness integrity and regulatory compliance. Ensure timely disposition decision for RM PM & FG in SAP.
- Maintain and ensure the qualification calibration and preventive maintenance of laboratory instruments/equipment.
- Investigate laboratory deviations OOS results and other non-conformances; support root cause analysis and CAPA implementation to avoid recurrence.
- Manage sample retention reference/working standards and inventory of lab chemicals reagents glassware spares & consumables to support uninterrupted lab operations.
- Maintain all standard validated test methods test reports certificate of analysis/conformance and other laboratory records (paper based or electronic) in a manner that facilitates easy archival & retrieval and meets the FDA requirements.
- Ensure test method development validation and transfer activities as & when needed.
- Deploy effective statistical Quality Control (SQC) checks and measures on the shop floor to meet the product quality standards on an ongoing basis.
- Ensure compliance with Good Laboratory Practices (GLP) Good Documentation Practices (GDP) and data integrity (ALCOA) requirements.
- Participate and assist during client audits and regulatory inspections; ensure audit readiness of all lab systems and documentation.
- Monitor and report lab KPIs such as turnaround times repeat testing and OOS trends to the management with a mindset of continuous improvement.
- Ensure adequate safety training for all lab analysts to maintain a safe working environment in the lab.
Deliverables:
- Successful outcome of Inspections & Audits by the Health Authority (USFDA) 3rd party certification agencies and clients (existing & potential) for QC Lab operations.
- All materials & components released for manufacturing and all products released for shipment to clients meet their respective specifications and regulatory requirements.
- Effective (accurate & compliant) Efficient (lead time & cost) and Safe (accident-free) operation of Quality Control laboratory.
Note:
The above statements shall not be construed as a complete description of all the work requirements.
VVF is an equal opportunity employer. We evaluate qualified applicants without regard to race color religion national origin sex or gender age disability veteran status sexual orientation gender identity or expression genetic information including the perception that a person has any of those characteristics or that the person is associated with a person who has or is perceived to have any of those characteristics or any other consideration made unlawful by applicable law. VVF is committed to working with and providing reasonable accommodations to individuals with disabilities. If you need a reasonable accommodation because of a disability for any part of the employment process please send us an email or call Human Resources and let us know the nature of your request and your contact information.
Required Experience:
Manager
Employment Type
Full-Time
