Description

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

Qualifications

PROFILE

• Bachelor’s degree related to scientific area is required.
• Minimum 3 years working experience in Quality Assurance in Pharma industry is required.
• Demonstrated understanding of relevant GMP (Good Manufacturing Practice) regulations is required.  Knowledge in compendiums such as USP is preferred.
• Proficiency in Microsoft Office applications, including Outlook, Word, and Excel. Ability to learn quickly new technologies.
• Excellent written and strong verbal communication skills in English (C1)
• Protocol and report writing compliant with regulatory standards.

REQUIRED SKILLS

• Strong written and verbal communication skills in English (B2+).
• Proven ability to manage and coordinate multiple tasks in a fast-paced, professional environment.   
• Proven time management skills and proficient in effectively prioritizing tasks to meet deadlines set by Supervisors.
• Detail-oriented with the ability to identify minor discrepancies.

Additional Info

Company Description

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.