QA Specialist (Validation/ GMP/ CAPA/ Pharma)

QA Specialist (Validation/ GMP/ CAPA/ Pharma)

12 Months Contract

Location: Tuas

Up to $5,000 depending on experience

Industry: Pharmaceutical

Our client aims at creating a new manufacturing concept consisting of a new generation of evolutive multi-product facilities, modular, adaptable, and agile, leveraging new disruptive technologies, to better address vaccine business challenges.

Job Purpose

• Partnering with site GMP operations and validation team in solving complex problems to ensure quality, safety, reliability, efficiencies and manage multiple quality systems including, but not limited to change controls, validation, deviations, laboratory investigations and CAPAs.
• Assist in the daily operations for Batch Record Review, Batch Disposition/ Release, complex deviations and continuous improvement projects.
• Ensure the compliance of qualification and validation with applicable regulatory requirements and company quality standards.

Responsibilities:

• Daily routine GMP documentation review activities (e.g. Batch record review and cleaning records of manufactured batches) of active pharmaceutical ingredients and intermediates in a timely manner by ensuring all the quality aspects of the batches are fulfilled according to GMP requirement.
• Daily batch review and release of the manufactured batches i.e., active pharmaceutical ingredients and intermediates to fulfil the cycle time for the key quality indicator.
• Participate actively in the GEMBA walk-down during investigation to triage and resolve on-the-floor manufacturing issues. Review and approve investigation by leading complex root cause investigations for manufactured batches that are implicated by Deviation/OOS/OOT/ILI. Highly focus on complex deviation records by ensuring that investigations are deep dive and scientifically justified to withstand scrutiny during the batch review/disposition/release decision.
• Monitor the progress of effective corrective and preventive (CAPA) actions to ensure timely closure of CAPA (key site performance metrics). Collaborate with site operation on problem prevention activities and system improvements.
• Proper evaluation (validation expertise) of change controls by ensuring all qualification and validation activities comply with regulatory requirements (e.g., FDA, EMA) and company quality standards.
• Oversight of qualification and validation activities i.e., reviewing and approval of qualification and validation documentation which include test scripts, protocols, reports and risk assessments according to pre-defined timelines. Ensuring proper documentation of deviations, non-conformances, and corrective actions during validation activities.
• Identifying opportunities for improving qualification and validation processes and contribute to continuous improvement initiatives. Support improvement projects by ensuring the validation/qualification are executed with conformance to GMP e.g., review of validation/qualification protocols and reports.
• Support in audits and regulatory inspections (if any). Participating in internal and external audits and inspections, providing necessary documentation and support. Prepare internal and external audits and HA inspections related to validation and qualification by identifying Q&V risks and propose mitigation plan.
• Training: To complete all GMP mandatory and related trainings.
• Facilitate daily level 2 quality meeting. Backup as QA Executive for QA team. Support monthly joint GEMBA- backup as QA Specialists for QA team.
• Play a pro-active role by complying and adhering to HSE guidelines. Embrace always Zero Incident Mindset and adopt the responsibility of HSE protection policies and Life Saving Rules (LSR).
• Other responsibilities that are not included in the above but are related to quality assurance and in accordance with internal guidelines and SOP.

Requirements:

• Hold an Engineering/ Science Degree or equivalent from recognised institution with 3-6 years of experience in Quality Operations in the pharmaceutical/biotech
• Validation experience
• Familiarity with batch disposition process using SAP system.
• A quick learner with a proactive ‘Can-do’ attitude. Adaptable and flexible in managing rapidly changing priorities, with a commitment supporting site validation activities in alignment with the manufacturing schedule.