Société Générale de Surveillance

Testing, inspection, and certification services globally

Pharma Quality Assurance Officer

Regulatory & Quality (Life Sciences)Posted on Nov 9

Full-timeMuntinlupa, Metro Manila, PhilippinesNo salary listed

About the Job

Requirements

A bachelor's degree related to a scientific area is required.
At least 3 years of work experience in Quality Assurance in the pharmaceutical industry is required.
Demonstrated understanding of relevant Good Manufacturing Practice regulations is required.
Proficiency in Microsoft Office applications, including Outlook, Word, and Excel, is required, along with the ability to learn new technologies quickly.
Strong written and verbal communication skills in English at B2+ or C1 level are required.
Ability to write protocols and reports compliant with regulatory standards is required.
Ability to manage and coordinate multiple tasks in a fast-paced professional environment is required.
Time-management skills and the ability to prioritize tasks effectively to meet supervisors' deadlines are required.
Attention to detail and ability to identify minor discrepancies are required.

Responsibilities

Review and approve Change Control Requests (CCRs), coordinating with owners and following up to ensure timely closure.
Serve as the site representative for training and document-control systems and manage related activities.
Track upcoming periodic document reviews and ensure they are completed on time.
Set up documents in the Document Management System (DMS) and coordinate their approvals.
Track training assigned to site employees, follow up to ensure timely completion, and evaluate retraining requirements for standard operating procedures (SOPs).
Maintain and update client test methods and specification databases.
Coordinate internal and external approvals of Quality Agreements with the SGS legal team and follow up with clients for timely approvals.
Coordinate customer and regulatory audits, prepare client responses to audit findings as assigned, and participate in the internal audit team when required, following up on related corrective actions.
Back up the QA Associate by releasing Certificates of Analysis.
Provide backup in designated areas in the absence of QA management.
Maintain the vendor evaluation program as an active backup by completing evaluations and vendor follow-ups on time.
Review method/specification assessment forms when provided.
Work on special projects assigned by management.
Complete assigned tasks on time and promptly notify the GBS Team Coordinator, or the section Lab Manager in their absence, of foreseeable delays.
Support operational improvement activities communicated by the GBS Supervisor, focusing on quality and efficiency.
Comply with the SGS Code of Integrity and Professional Conduct and SGS Quality, Health, Safety and Environment (QHSE) requirements.

Desired Qualifications

Knowledge of compendiums such as the United States Pharmacopeia (USP) is preferred.

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
For working set up: 3 months onsite, transitioning to a hybrid setup thereafter.

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 Information

About the Company

Société Générale de Surveillance

Testing, inspection, and certification services globally

SGS provides testing, inspection, and certification services to help clients meet regulations, ensure quality and safety, and gain market access. It runs laboratory testing, on-site inspections, and certification against standards, often with training and consulting, across a wide range of industries. The services rely on a global network of laboratories and offices that deliver localized solutions with global expertise. What sets SGS apart is its large global footprint and its emphasis on quality, integrity, risk mitigation, and sustainability, enabling it to serve a diverse set of customers from small businesses to multinationals. The company's goal is to help customers comply with regulations, improve product quality and safety, reduce risk, and boost productivity across markets.

Company size: 10,001+
Company stage: IPO
Headquarters: Geneva, Switzerland
Founded: 1878

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