Quality Assurance (Shift Operation)

INTEGRIX SOLUTIONS PTE. LTD.; Singapore; On-site; SGD 60,000 - 80,000; Full time

Job summary

A leading pharmaceutical firm in Singapore is seeking an Operational Quality Oversight Specialist to ensure adherence to cGxP standards and support quality compliance across operations. This role requires maintaining a strong presence on-site, providing real-time guidance, and conducting compliance checks to identify and prevent quality risks. Ideal candidates possess experience in regulated environments and demonstrate a commitment to fostering a culture of quality across teams. The position operates on a 12-hour shift pattern.

Qualifications

• Experience in cGxP environments and compliance standards.
• Strong observational skills for identifying quality risks.
• Ability to perform real-time observations and interventions.

Responsibilities

• Ensure compliance with GMP processes and internal procedures.
• Provide real-time guidance during GMP activities.
• Conduct spot-checks across production and laboratory areas.
• Review documentation and batch records for accuracy.

Job description

Job Title: Operational Quality (OQ) Oversight

Department: Quality

Reporting to: Operational Quality Manager

Job Role:

We invite highly motivated individuals to join our team to provide support to our clients’ facilities. This role is to ensure robust adherence to cGxP standards and internal procedures through independent oversight of GxP‑related processes. The role supports the effectiveness of the site’s quality system by proactively preventing, identifying and addressing quality risks, while fostering a strong quality culture and continuous improvement mindset across operations. The position requires maintaining a visible presence on the shop floor and being accountable for key quality decisions, including timely escalation and resolution of quality issues. To provide adequate quality coverage across production, this role operates on a 12‑hour shift (2-2-3 Panama shift pattern) aligned to manufacturing operating hours.

Key Responsibilities

• Ensure that all GMP processes and operational personnel comply with current local and area specific procedures, minimising risk of non‑compliance and maintaining inspection readiness at all times.
• Maintain a strong presence in the assigned operational areas, acting as the first point of contact for initial management of quality issues and be accountable for key quality decisions, including supporting initial impact assessment for deviations.
• Provide real‑time guidance during GMP activities to proactively identify potential quality risks through active on‑the‑floor observation, enabling timely intervention to prevent deviations and defects.
• Authorise key QA processes such as production changeover activities, quality tag‑outs of equipment and facilities, buffer and material release, and inspection lot usage decisions.
• Conduct spot‑checks across production, warehouse and laboratory areas to ensure compliance with GMP standards, covering activities such as production, testing, cleaning and equipment maintenance.
• Ensure required oversight frequencies for critical activities, records and data and GMP exceptions are adhered to, in line with risk assessment strategy and procedural requirements. This includes review of CPP/CQAs and oversight of critical GMP alarms and audit trails.
• Perform real‑time review of documentation and batch records to ensure content accuracy, appropriately handling of exceptions and adherence to Good Documentation Practices (GDP) aligned with ALCOA+ principles for data integrity, audit and traceability.
• Verify that facilities are being maintained in a good state in line with local housekeeping standards and escalates any deviation from the standards promptly ensuring associated remedial and corrective actions are implemented in a timely manner.
• Role model the Pharma Production System standards and foster a Quality Starts With client QA culture by coaching employees on the importance of compliance, doing the right thing and the impact of non‑compliance on product quality and patient safety.

Employment Type

1 year Contract, Full Time. This role operates on a 12‑hour shift pattern (2‑2‑3 Panama shift pattern) aligned to manufacturing operating hours.