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

Our Client, a healthcare MNC, is currently on the 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, propose mitigation plans.
• Participate in validation discrepancy investigations and assist in the writing and review of the discrepancy report
• Track all validation discrepancies and their 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 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 partnerships with all other departments to ensure open communications and acceptance
• Commit to a fair and respectful relationship with 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, Incubators, 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, testers), commercial off-the-shelves (COTS) analytical instruments, freezers.
• Experienced in creating, reviewing, and approving equipment qualification and analytical instruments lifecycle documentations, e.g., FAT, SAT, IQ, OQ, PQ protocols and reports, risk assessments, technical specifications.
• Can lead investigations revolving around discrepancies identified during qualification activities.
• Experience in coordinating 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 teams 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 preferred)
• Regular progress reports 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
• Represents Automation in working meetings providing technical advice on the fulfillment of production targets and operational effectiveness
• Plans projects or subtasks so they may be tracked and presented.
• Implements complex changes or modifications
• Provides out-of-hours technical support to address and rectify technical issues and queries on a rotational basis
• Provides systems training for end-users
• Investigates and supports on complex issues. Escalates to the Sr Engineers if the need arises due to the complexity of the issues
• Adheres to the budget as defined
• Supports Audit requests with general supervision from Sr Engineers and Manager
• Complies and suggests improvements on quality-related documents of the department (e.g., SOPs, CAPAs, Change Controls, Specifications, etc.)
• Supports activities that will ensure the integrity of quality-related electronic data within the systems.
• Coordinates, supports, and executes (if needed) necessary spares management, routines, preventive, and corrective maintenance plans in consideration of the production schedule
• Responsible for adhering to any applicable EHS requirements.
• Commitment to a fair and respectful relationship with others and behavior in accordance with the Code of Conduct.
• Any other duties as assigned by supervisor.

Education and Experience Requirements

• Proficient in the use of MS Office
• Proficient in technical writing 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 aspects under GMP environment
• Proficient in the application of risk assessment such as FMEA
• Excellent communication skills (verbal and written) 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 leonleong@recruitexpress.com.sg

(Attn: Quality Systems Specialist / Validation Engineer / Automation Engineer)

Thank You.

Recruiter's Ref Code: #HDC
Recruit Express Pte Ltd (Healthcare & Lifesciences Division)
EA License: 99C4599