GBS H&N Pharma Quality Assurance Associate

Job 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.