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Life Sciences Services (LSS) from SGS – optimize your development timelines to get medicines and medical devices to market quickly and safely. As a result, we are often a preferred partner for the top 20 pharmaceutical and biotechnology companies.
Job Summary:The duties of the Quality Assurance Team Manager are twofold. One is to perform the functions defined by Good Manufacturing Practices (GMP) and Good Laboratory Practice (GLP) regulations.
The other is to help oversee the management of all quality systems at the laboratory and communicate the status of those systems to the Director and executive management. This is accomplished primarily through management and auditing functions.
Specific tasks may be delegated to additional staff with the understanding that the QA Assistant Manager and Director retain oversight authority and responsibility in these areas. Overall, the QA Assistant Manager’s role is crucial to the success of the laboratory, and presents the employee with a unique and rewarding set of challenges.
Service Responsibilities to internal & external stakeholders
- Act as a liaison to client auditors and regulatory inspectors. Host and coordinate inspections involving the company officer and department heads as necessary with regulatory agents on site.
- Prepare responses to audit reports from clients and regulatory agencies.
- Administer system(s) for handling client problems or complaints.
- Act as a regulatory resource for SGS clients. Ensure that all client request for information pertaining to current regulations are met promptly and effectively.
- Provide laboratory staff and management with current regulations and industry compliance news by attending industry meetings and workshops and by acquiring and evaluating current guidelines.
- Together with other department managers and directors, plan for cross-departmental workshop training as needed. Plan and hold group one-on-one continued training on issues pertaining to regulatory compliance.
- Involve staff in audit follow-up procedures for the purpose of instruction, feedback, and continuing staff development.
- Compliance-driven projects. Quality improvements to increase the laboratories’ level of compliance (e.g. process validation, documentation systems).
- Competitive advantage projects. Quality improvements to increase laboratory efficiency of decrease quality costs thereby providing the company with a competitive advantage.
- Measurement and feedback projects. Projects designed to measure specific quality parameters and provide organized, evaluated information to corporate officers and department heads. These include programs that measure report error rates, turnaround time, customer satisfaction, etc.
- Approve and Issue Certificate of Analysis.
Core GLP, GMP/ISO Responsibilities:
- Perform in-life audits of GLP studies.
- Perform final audits of GLP reports.
- Assist in the maintenance of the Master Schedule and archives.
- Assist in coordinating and conducting regular management Review Meetings.
- Perform internal audits of departments, data, systems, and facilities. Report findings to management. Organize and plan follow-up inspections as part of corrective action processes.
- Perform audits of vendors and subcontractors as mandated by management.
- Write SOPs pertaining directly to quality functions.
- Oversee archiving of non-GLP documentation per internal retention requirements.
- Provide new employees with appropriate training documents.
- Provide all employees with training in GMP, GLP, ISO, and other applicable regulations as well as the role of quality assurance in the laboratory.
- Review new or revised SOPs generated at the facility (as assigned).