Validation Lifecycle Specialist
6 days ago
Nusantara Prime Consulting PTE. LTD., a reputable consulting firm, is seeking a skilled Validation Lifecycle Specialist to join our team.
Job Description:
We are looking for an experienced Validation Lifecycle Specialist with a strong background in pharmaceutical industry to manage and execute validation lifecycle documents, protocols, reports, and deliverables in accordance with relevant policies, standards, procedures, and guidelines.
Responsibilities:
- Develop, review, and/or approve validation lifecycle documents and protocols/reports and deliverables in accordance with relevant policies, standards, procedures, and guidelines.
- Lead and review project design documents (P&IDs, PFDs, URS etc.)
- Define user requirements and create SOPs or documentation related to the validation activities
- Manage qualification execution and lead validation deviation investigation encountered in qualification.
- Create and review validation lifecycle documents: User Requirement Specification, Functional Specification, Risk Assessments, Validation Protocols (IQ/OQ/PQ/CPV) and Reports, Study Protocols and Reports, Requirement Traceability Matrix, CFR Part 11 assessment and validation submission dossier
- Collaborate with multi-functions to arrange, plan, and ensure smooth running of the qualification activities
- Participate in site Validation Maintenance Program
- Write execution-related deviations and change requests
- Support change implementation on site.
- Manage Change Control to update SOPs, Risk Assessment, Requirement Traceability Matrix, and/or Automation System Life cycle documentation as needed.
- Perform validation documentation and/or support validation documentation in accordance to the division procedures
- Regular preview of pending activities to maintain validation status with validation lead, supervisor, or manager
- Ensure validation execution meets compliance, validation standards, and cGMP requirements.
About You:
- Diploma/Degree in Engineering or Science Disciplines with 3 to 5 years experience in Pharmaceutical Industry
- Proven track record in Equipment Qualification for HVAC and Utilities Validation (IQ/OQ/PQ/CPV)
- In-depth knowledge on cGMP, GDP, and ASTM E2500
- Proactive and self-motivated
- Demonstrated proficiency of written and verbal communication skills in English (including technical writing and presentations)
- Effective Project Management, leadership, communication, and interpersonal skills.
What We Offer:
- Estimated salary SGD $90,000 per annum, based on experience
- Opportunity to work with a reputable consulting firm
- Collaborative and dynamic working environment
- Professional growth and development opportunities
- Competitive benefits package
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