Validation Lead
3 weeks ago
Location: Pune, India
Job Type: On-Site
Long term program: 18 months
Work Experience: 7-10 years
Validation Requirements:
US West Coast Customer, overlap for first half of the day in the US, Another client is Europe based.
Working hours:
VL: 12 noon – 9 pm IST (Validation Lead )
Requirements:
Pharma application areas: Clinical domain - PV/Argus, CTMS applications, SaaS platform, AWS, manufacturing. QMS
Responsibilities:
Partner with key business stakeholders to develop policies and procedures necessary to lead/guide the implementation and maintenance of a compliant, efficient, and integrated CSV program.
Perform System Risk Assessment
Create the end-to-end Validation Plan/Strategy
Review Requirement Specifications including Regulatory & non-functional requirements.
Review the Technical Design document and solution architecture.
Perform Requirement Risk Assessment
Author Test Plan
Review Pre-executed and post executed IQ, OQ and PQ Scripts
Review IQ/OQ/PQ Summary & Traceability Matrix
Create Validation Summary Report
Manage Change Controls
Perform Periodic Review and manage CAPA
Provide SME support on topics relevant to GxP, CSV, 21 CFR Part 11, Annex 11 etc.
Qualifications:
Bachelor's/master’s degree in engineering, Science, Medical or related field.
Hands-on experience in Computer System Validation of Applications and Infrastructure Qualification.
A minimum of 5-10 years of experience in computer systems validation and hands on experience within GxP (GCP/GMP regulated environment (FDA, EU, MHRA)).
Strong working knowledge and experience of global regulations and guidelines such as GAMP, CFR Part 11 Annex 11 and other FDA regulations i.e. 21 CFR Part 210, 211, Part 820, ICH Q9, QSRs, ISO 13485, HIPPA etc. coupled with ability to practically apply such knowledge.
Strong knowledge of industry standards like GAMP5, FDA 21 CFR Part 11 on electronic records, electronic signatures etc.
A thorough understanding of drug development processes from discovery through development and post-marketing, with an ability to understand business requirements and translate them into practical solutions.
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