Quality Systems Specialist / Validation Engineer/ Automation Engineer (Pharma)

Recruit Express Pte Ltd| Date Posted: 10-Feb-2020
EA Licence No: 99C4599|EA Personal Registration No: R1551708
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Job Nature:
Permanent, Contract
Position Level:
Experienced, Manager
Diploma, Bachelor's / Honours, Masters / PhD

Job Description

Our Client, a healthcare MNCs are currently on a lookout for:

1. Quality Systems Specialist

2. Validation Specialist

3. Automation Engineer


Do feel free to drop us your resume and we'll get back to you shortly on this!! All are welcome to apply!


1. Quality Systems Specialist


• Member of the Quality Systems team in ensuring Quality oversight for validation activities
• Participate in the development and writing of procedures pertaining to the validation procedures.
• Partner with the SME, assist the Validation team with gap analysis/risk assessment prior to qualification activities, and where gaps are identified, proposed mitigation plans.
• Participate in validation discrepancy investigations and assist in the writing and review of the discrepancy report
• Tracking of all validation discrepancy and its associated CAPA closure
• Review and approve validation documents not limited to protocols and reports
• Provide support with any validation queries and issues
• Provide feedback/recommendation to facilities change controls and intervention to the critical systems/utilities
• Assess for validation impact for process improvements/studies with SMEs and the manufacturing team
• Support the compliance, regulatory, audits and training activities as required, and any other responsibilities as assigned by Quality Systems Supervisor
• Adhere to any applicable EHS, Regulatory and corporate requirements.
• Build strong partnership with all other departments to ensure open communications and acceptance
• Commit to a fair and respectful relationship to others and behavior in accordance with Shire’s Code of Conduct.
• Carry out any other duties as assigned by Quality Systems Supervisor



2. Validation Specialist


The key responsibilities of the Validation Specialist are as follows:
• Planning, Performance, and Coordination of Computer System Validation, Equipment Qualification, Temperature Controlled Objects (Freezers, Incubator etc), Clean Utilities Validation and cleaning validation in accordance with internal procedures and industry standards.
• The qualification includes, FAT, SAT, IQ, OQ, PQ of any additional / modifications of existing manufacturing process equipment, package units (e.g. Ultrafiltration Unit, Chromatography Columns, autoclave, FIT testers), commercial off the shelves (COTS) analytical instruments, freezers,
• Experienced to creates, reviews and approve equipment qualification and analytical instruments lifecycle documentations, e.g. FAT, SAT, IQ, OQ, PQ protocols and reports, risk assessments, technical specifications.
• Can lead investigation revolving around discrepancies identified during qualification activities.
• Experience in coordinate the commissioning and qualification activities (including the creation, pre-execution approval, execution, post-execution review, and post-execution approval of all validation lifecycle documents)
• Experience in leading daily validation meetings with cross functional in resolving validation issues.
• Experience in equipment qualification including analytical instrumentation and manufacturing equipment.
• Experience in ASTM2500 of process equipment commissioning and qualification (Ultrafiltration units and chromatography column is preferred)
• Regular progress report of project deliverables to supervisor/project lead
• Any other duties as assigned by supervisor/designated person.


3. Automation Engineer


• Works on many phases or sub-tasks of project or entire projects of moderate complexity
• Represent Automation in working meeting providing technical advice on the fulfillment of production targets and operational effectiveness
• Plans projects or subtasks so they may be tracked and presented.
• Implement complex changes or modifications
• Provide out-of-hours technical support to address and rectify technical issues and queries per rotational basis
• Provide systems training for end-users
• Investigate and support on complex issues. Escalate to the Sr Engineers if the need arises due to the complexity of the issues
• Adhere to the budget per defined
• Support Audit request with general supervision from Sr Engineers and Manager
• Comply and suggest improvement on quality related documents of the department. (e.g. SOP´s, CAPAs, Change Controls, Specifications etc.
• Support activities that will ensure the integrity of quality related electronic data within the systems.
• Coordinate, support and execute (if needed) necessary spares management, routines, preventive and corrective maintenance plan in consideration of the production schedule
• Responsibility to adhere to any applicable EHS requirements.
• Commitment to a fair and respectful relationship to others and behavior in accordance with Code of Conduct.
• Any other duties as assigned by supervisor.



Education and Experience Requirements

• Proficient in use of MS Office
• Proficient in technical write up of validation lifecycle documentation (e.g. validation project plan, validation protocols, validation reports, validation discrepancies)
• Flexible working hours based on project schedule/timeline
• Experience in quality management systems is preferred
• Knowledge in validation aspect under GMP environment
• Proficient in application of risk assessment such as FMEA
• Excellent communication skills (verbal and writing) and analytical thinking.
• Able to execute activities in cGMP environment, including cleanrooms or technical areas.


If you are interested in the position, do kindly drop your most updated resume to [Click Here to Email Your Resume] (Attn: Quality Systems Specialist / Validation Engineer/ Automation Engineer)

Thank You.

Leon Leong De Cong
Recruit Express Pte Ltd (Healthcare & Lifesciences Division)
EA License: 99C4599


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Recruit Express Pte Ltd