PRIMARY RESPONSIBILITIES
- Review and approve Change Control Request and ensure their timely closure by coordinating with owners.
- Act as site representative for Trainings and Document Control systems and manage related activities.
- Maintain client test methods, specification databases, and coordinate Quality Agreement approvals internally, externally, and with Legal.
- Coordinate and support internal, client, and regulatory audits, and prepare responses to audit findings.
- Act as backup for QA functions, including release of Certificates of Analysis, vendor evaluations, and other QA management responsibilities.
- Follows Training SOP for training and training records.
REPORTING LINE
Operational direct reporting to Affiliate lab manager or supervisor; administrative accountability to GBS Supervisor.
SPECIFIC RESPONSIBILITIES
- Review and approve CCRs and coordinate for their timely closure by periodic follow up with associated CR owners.
- Be site representative for Trainings and Document control systems and manage all the activities for these programs.
- Responsible for keeping track of upcoming periodic reviews of documents and ensure their timely completion.
- Set up all the documents in DMS and coordinate for their approvals.
- Responsible for keeping track of trainings assigned to all site employees and ensure their timely completion by periodic follow ups.
- Evaluate all re-training requirements for the SOPs.
- Maintain and update client test methods and specification data bases.
- Coordinate approvals of Quality Agreements internally, externally and with SGS legal team.
- Follow up with clients for timely approvals of quality agreements.
- Coordinate internally for customer and regulatory audits.
- Prepare client responses to audit findings, as assigned.
- Be backup for QA Associate and release the certificate of analysis.
- Work as a backup in some designated areas in the absence of QA management.
- As active back up, maintain vendor evaluation program by timely performing the evaluations and follow ups with the vendors.
- Review method/specifications assessment form, if provided.
- Be part of internal audit team when required and follow up on related corrective actions.
- Work on special projects as assigned by the Management.
- Ensures the tasks assigned are accomplished in due time. In case of foreseeable delay, the GBS Team Coordinator (or section Lab Manager in their absence) is notified immediately.
- Adopts and supports specific operational improvement activities, as communicated by the GBS Supervisor, with focus on the improvement of quality and efficiency.
- Performs other related duties as may be assigned either in support of departmental goals or for his/her personal or professional training, education or development as programmed by his/her immediate superior.
- At all times, comply with SGS Code of Integrity and Professional Conduct and with all SGS QHSE
- For working set up: 3 months onsite, transitioning to a hybrid setup thereafter.