Senior Life Sciences ValidationQA Lead
Senior Life Sciences ValidationQA Lead
Posted on :
27-10-2024
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Job Description
Job Title: Senior Life Sciences Validation/QA Lead
100% Remote
Long term Project
Job Summary: We are seeking a highly experienced Senior Life Sciences Validation/QA Lead to join our team. The successful candidate will be responsible for leading validation and quality assurance activities to ensure compliance with regulatory standards and the highest quality of our products and processes.
Key Responsibilities:
- Develop and Execute Validation Protocols:
- Create and implement validation protocols for equipment processes and systems.
- Oversee equipment qualification process validation and computer system validation.
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- Quality Assurance Leadership:
- Lead the QA team in designing and implementing QA processes standards and methodologies.
- Ensure all validation activities comply with regulatory requirements and industry standards such as cGMP.
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- Documentation and Compliance:
- Oversee the creation and approval of validation documentation including SOPs change controls CAPAs and deviations.
- Ensure all documentation meets regulatory and company standards.
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- Risk Management:
- Identify and manage risks associated with validation activities.
- Ensure critical parameters are controlled and maintained.
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- Team Leadership and Development:
- Mentor and lead a team of QA professionals.
- Coordinate team activities and ensure alignment with project goals.
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- Stakeholder Collaboration:
- Work closely with project stakeholders to define testing objectives and deliverables.
- Ensure QA activities meet project requirements and timelines.
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Qualifications:
- Bachelors or Masters degree in Life Sciences Engineering or a related field.
- Minimum of 810 years of experience in validation and quality assurance within the life sciences industry.
- Strong knowledge of regulatory requirements and industry standards (e.g. cGMP FDA EMA).
- Excellent leadership communication and project management skills.
- Ability to work collaboratively with crossfunctional teams.
Preferred Skills:
- Experience with risk management and mitigation strategies.
- Proficiency in validation software and tools.
- Certification in Quality Assurance or related fields.
Thanks & Regards
Hari
Employment Type
Full Time
Key Skills
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