Hi ,
Greetings from Uniqsoft INC!!!
We have "Validation Lead" Open positions at "Remote" – Long term Contract position.
Job Title: Validation Lead
Location: Remote
Position type: Long term Contract
Job Description:
Develop and execute validation plans, protocols, and reports for new product development, process improvements, and equipment qualification.
Collaborate with cross-functional teams, including application, quality assurance, and regulatory affairs, to define validation requirements and ensure compliance with applicable regulations and standards.
Perform risk assessments to identify potential validation issues and develop mitigation strategies.
Design and execute validation tests, including GxP application flow, to verify system functionality, performance, and reliability.
Analyze validation test data and generate comprehensive reports, highlighting any deviations or non-conformances and proposing corrective actions.
Conduct root cause analysis investigations for validation failures or non-conformances and implement corrective and preventive actions (CAPAs) to address identified issues.
Maintain accurate documentation of validation activities, including protocols, reports, standard operating procedures (SOPs), and change control records.
Collaborate with suppliers and vendors to ensure their products meet validation requirements and assist in supplier audits when necessary.
Stay current with industry trends, regulatory guidelines, and best practices related to validation engineering.
Contribute to continuous improvement efforts by identifying opportunities to streamline validation processes and enhance overall efficiency.
Document Validation Summary Report and Requirements Traceability Matrix
Support actions related to Change Management, Deviations and CAPAs
Primary (Must have skills)*
Proven experience in validation engineering, preferably in a regulated industry such as pharmaceuticals, medical devices, or biotechnology.
Strong knowledge of validation principles, methodologies, and regulatory requirements (e.g., FDA, ISO, GMP).
Well versed in HP ALM tool (for writing, approving and executing test scripts.)
Solid Manual QA work experience
Excellent analytical and problem-solving skills, with the ability to analyze complex data sets and identify trends and patterns.
Detail-oriented mindset with strong organizational and documentation skills
Secondary Skills (Good To have)*
Working knowledge of Agile methodology
Onsite-offshore coordination experience will be a plus
Soft skills/other skills (If any)
Effective communication and interpersonal skills to collaborate with cross-functional teams and external stakeholders.
Educational Qualification*
Bachelor’s degree in Computers or equivalent
Skills Matrix:
Total work experience in IT Industry:
Total work experience in USA:
Validation Lead: Years
Validation principles: Years
HP ALM tool: Years
Executing test scripts: Years
Agile methodology: Years
and Have A Wonderful Day,
Srikanth
(Technical Recruiter)
Uniqsoft INC, |4025 Tiber Falls Dr, Ellicott City, MD 21043 |
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