SGS is the world’s leading inspection, verification, testing and certification company. SGS is recognized as the global benchmark for quality and integrity. With more than 94,000 employees, SGS operates a network of over 2,600 offices and laboratories around the world.
Job Description
PRIMARY RESPONSIBILITIES
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Review and approve Change Control Request and ensure their timely closure by coordinating with owners.
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Act as site representative for Trainings and Document Control systems and manage related activities.
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Maintain client test methods, specification databases, and coordinate Quality Agreement approvals internally, externally, and with Legal.
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Coordinate and support internal, client, and regulatory audits, and prepare responses to audit findings.
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Act as backup for QA functions, including release of Certificates of Analysis, vendor evaluations, and other QA management responsibilities.
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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
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Review and approve CCRs and coordinate for their timely closure by periodic follow up with associated CR owners.
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Be site representative for Trainings and Document control systems and manage all the activities for these programs.
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Responsible for keeping track of upcoming periodic reviews of documents and ensure their timely completion.
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Set up all the documents in DMS and coordinate for their approvals.
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Responsible for keeping track of trainings assigned to all site employees and ensure their timely completion by periodic follow ups.
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Evaluate all re-training requirements for the SOPs.
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Maintain and update client test methods and specification data bases.
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Coordinate approvals of Quality Agreements internally, externally and with SGS legal team.
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Follow up with clients for timely approvals of quality agreements.
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Coordinate internally for customer and regulatory audits.
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Prepare client responses to audit findings, as assigned.
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Be backup for QA Associate and release the certificate of analysis.
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Work as a backup in some designated areas in the absence of QA management.
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As active back up, maintain vendor evaluation program by timely performing the evaluations and follow ups with the vendors.
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Review method/specifications assessment form, if provided.
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Be part of internal audit team when required and follow up on related corrective actions.
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Work on special projects as assigned by the Management.
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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.
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Adopts and supports specific operational improvement activities, as communicated by the GBS Supervisor, with focus on the improvement of quality and efficiency.
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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.
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At all times, comply with SGS Code of Integrity and Professional Conduct and with all SGS QHSE
Qualifications
PROFILE
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Bachelor’s degree related to scientific area is required.
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Minimum 3 years working experience in Quality Assurance in Pharma industry is required.
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Demonstrated understanding of relevant GMP (Good Manufacturing Practice) regulations is required. Knowledge in compendiums such as USP is preferred.
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Proficiency in Microsoft Office applications, including Outlook, Word, and Excel. Ability to learn quickly new technologies.
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Excellent written and strong verbal communication skills in English (C1)
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Protocol and report writing compliant with regulatory standards.
REQUIRED SKILLS
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Strong written and verbal communication skills in English (B2+).
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Proven ability to manage and coordinate multiple tasks in a fast-paced, professional environment.
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Proven time management skills and proficient in effectively prioritizing tasks to meet deadlines set by Supervisors.
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Detail-oriented with the ability to identify minor discrepancies.