QA Specialist

Job title: QA Specialist

• Location: Jurong, Singapore

• Hiring Manager: Quality Assurance Manager

About the job:

As a Senior Quality Assurance (QA) Operations Specialist, you play a key role in 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. He/she will assist in the daily operations for Batch Record Review, Batch Disposition/Release, complex deviations and continuous improvement projects. He/she will also ensure the compliance of qualification and validation with applicable regulatory requirements and company quality standards.

Main Accountabilities:

• 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 requirements.

• 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.

• 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 in audits and regulatory inspections (if any). Participating in internal and external audits and inspections, providing necessary documentation and support.

• 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 assignments.

Key Involvement in Decision-Making Process

• Request corrections when GMP rules are not respected (D)

• Request quality improvement initiatives and strategies (D)

• Identify discrepancies and corrective/preventive actions that need to be done (D)

• Escalate to upper management any failure in GMP execution in shopfloor (I)

• Inform relevant stakeholders and team members of quality performance, corrective actions, findings, and preventive measures (I)

• Approve a batch record if it is correctly completed and meet the quality requirement for one lot (D)

• Check if all practices are done according to quality requirement - if not, assure that a deviation is opened and reported into the batch record (D)

• Review documentation for Batches disposition (A)

• Proactively implement remediation action from findings from internal and external audits related to quality issues (D)

• Advise on quality improvement initiatives and strategies (A)

• Escalate the issues when needed (I)

About you

Experience:

• You hold a bachelor degree or equivalent from recognised institution with minimum 3-5 years of experience in Quality operation and validation in the pharmaceutical/biotech industry or equivalent holders with a combination of education and relevant work experience.

• Quality operational experience is preferred

• Meaningful work experience in validation/quality unit in pharmaceutical/biotech industry.

• Familiarity with regulatory requirements and local codes & standard e.g., FDA, EMEA and ICHQ7.

• Fair knowledge of validation lifecycle approach (URS, FAT/SAT, commissioning, I/O/OQ/PQ protocols etc) and regulatory guidelines in a GMP facility. Familiarity with industry best practices for qualification of SAP system.

• Experience with investigations into manufacturing, laboratory deviations and product impact on potential root cause and corrective/preventive actions.

• 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. Discipline and assertiveness in the decision-making and execution of quality related issues.

• Exceptional time management skills with strong attention to detail.

• Able to work independently and write/review quality validation reports which include equipment /analytical validation and qualification activities. Strong interpersonal relationships in establishing good partnerships with cross functional teams.

• Excellent verbal and written communication skills; effective communication and presentation skills across different