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Validation Specialist (Biologics Manufacturing, Office Hours 5 days, Pharma)

Description

Responsibilities
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.


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 any of the positions, do kindly drop your most updated resume to leonleong@recruitexpress.com.sg   (Attn: Validation Specialist - Leon)


Thank You.

Leon Leong De Cong
R1551708

Recruit Express Pte Ltd (Healthcare & Lifesciences Division)
EA License: 99C4599


Industry

Architecture / Building / Construction
Banking & Finance
Conventions / Exhibitions / Events
Education & Training
FMCG / Retail
Freight Forwarding
Healthcare / Pharmaceutical / Life Science / Medical Device
Hospitality / F&B
Industrial Machinery / Heavy Equipment
Insurance
IT & Telecommunications
Logistics / Warehousing
Media & Advertising
Oil & Gas / Petroleum / Energy
Others
Production / Manufacturing
Public Sector / Government & Statutory Boards
Semiconductor / Electronics / Engineering


Specialization

Accounting / Auditing / Tax
Administrative Support / Secretarial
Banking & Finance
Chemist / Research Scientist
Customer Service
Engineering
Healthcare - Nurse / Allied Healthcare
Healthcare - Pharmaceutical / Life Science / Medical Device / Clinical Research / Regulatory Affairs
Hospitality / F&B
Human Resource
Insurance – Underwriting / Broking / Claims / Others
IT Applications (Software / ERP)
IT Infrastructure (Hardware)
IT Management (IT Manager / IT Dir / Head of IT / CIO / CTO)
IT Security / Governance / Risks / Compliance / Audit
Legal & Compliance
Marketing / Public Relations / Media / Advertising
Others
Procurement / Buyer / Merchandiser
Production / Manufacturing
Professional Services
Sales - Others
Sales - Retail
Senior Management
Transportation / Logistics / Supply Chain


Location

Central, North, East, West


Employment Type

Contract / Temp
Permanent


Salary

S$2,601 - S$4,000 / mth
S$4,001 - S$6,000 / mth


If you meet the requirements of this role, please email a detailed resume in Word document to Leon Leong De Cong.
CEI Registration No.: R1551708
Email: leonleong@recruitexpress.com.sg
*All information will be treated with strictest confidence. We regret that only short-listed applicants will be notified.