Job Description

• Pharmaceutical Industry-Monday to Friday-Flexible Compressed Work Arrangement (FCW)-Company Transport provided from various locations in Singapore-Good career progression-Remuneration: Up to $6,400 + Attractive Bonus & Benefits & Allowances-Salary will commensurate with Experience & QualificationsResponsibilities: Operational Readiness phase Provide quality oversight of Facilities and Equipment, Materials, Production, Laboratories, Packaging and Labelling systems and processes. This includes supporting PQS gap analysis, review and approval of new and updated site procedures. Review and approve process recipes, master batch records, cleaning instructions and associated documentation to ensure batches produced are in compliance with Company quality standards and regulatory registered specifications in support of initial process performance qualification of intermediate and active pharmaceutical ingredient (API) process steps. Provide support for updates to site platforms supporting quality systems (e.g. Trackwise, Vault QMS, SAP, PDOCs) as required. Play an active and impactful role to deliver flawless execution through critically reviewing systems, processes and interdependencies for GMP compliance and sustainability in routine operation.Routine production phase Responsible to review and approve recipes and GMP documentation (e.g. SOPs, batch records, change controls) associated with Facilities and Equipment, Materials, Production, Laboratories, Packaging and Labelling to ensure batches are produced and tested in compliance with site procedures and regulatory registered specifications. Disposition intermediates and active pharmaceutical ingredients (API). Review and approve deviations and laboratory investigations according to site procedures. This includes reviewing and approving the investigation reports, ensuring the adequacy of the root cause analysis and associated corrective actions and/or preventive actions, performing the impact assessment with the subject matter experts for quality/validation/stability/regulatory impact. Ensure issues are escalated according to site procedures. Handle product complaints. Ensure complaints are investigated thoroughly with effective CAPAs to prevent recurrence. Handle duties related to DPOC (Designated Point of Contact) and super user for assigned site platforms supporting quality systems (e.g. Trackwise, Vault QMS, SAP) as nominated. Maintain current quality tracking systems and quality metrics to proactively identify trends and atypical observations. Coordinate with cross-functional team to prepare Annual Product Record Reviews, discuss trends and atypical observations and recommend improvement actions. Participate in process risk assessments (e.g. FMEA) as part of new product introductions and/or process changes. Participate in gap analysis of site procedures against PQS and propose required actions to address identified gaps and mitigate risks. Conduct internal audits to ensure the internal controls are effective. Maintain inspection readiness and support inspections from regulatory agencies and customers. Actively participate in GMP walk downs to ensure site operation and facility maintained in inspection ready state and adhere to site procedures and PQS. Support the maintenance of validated state of GMP systems and processes. Support regulatory submissions and attend to regulatory queries in a timely manner. Uphold company's code of conduct and values. Play an active and impactful role in Tier processes by updating performance against metrics, highlighting & resolving issues, with appropriate escalations. Develop courses of action and drive implementation of solutions. Collaborate with cross-functional teams to drive flawless execution. Mentor junior members (including interns) within the Quality Assurance team. Actively participate in Safety initiatives, and perform investigation related to EHS (as needed).Requirements: Degree in Chemistry, Microbiology, Engineering or other Science related discipline. Diploma in Science related discipline with a minimum of 6-8 years experience in Quality Assurance role within the pharmaceutical industry will be considered. Embrace the use of digital technology to scale and speed up every form of interaction and action Minimum 4 years experience (including Quality Assurance roles) within the pharmaceutical industry. Compliance, regulatory or validation experience is an advantage. Demonstrated personal leadership, accountability, and organizational skills with proven ability to operate independently with minimal supervision. Experience working in a cross-functional, matrix environment is an advantage.To proceed, click on the APPLY NOWEA License | 14C7092EA Registration Number | R22105949 (Ruishen Guo)