| ValidationLead || Indianapolis,IN (onsite 5 days week) at Indianapolis, Indiana, USA |
| Email: [email protected] |
| From: Shaikh Mubashir, kk software associates [email protected] Reply to: [email protected] Hi, Greetings from KK Software Associates. This is Shaikh Mubashir from KK Software Associates. I have an urgent requirement of Validation Lead please go through the below requirement and forward me your updated resume with contact details ASAP. Title: Validation Lead Location: Indianapolis, IN (onsite 5 days week) Contract: 12+ Months Job Summary: We are seeking a highly skilled Validation Lead to oversee and manage the validation processes for our projects. The ideal candidate will have extensive experience in validation within regulated environments, ensuring compliance with industry standards and regulations. Key Responsibilities: Validation Strategy: Develop and implement validation strategies and plans for projects, ensuring alignment with regulatory requirements and organizational standards. Team Leadership: Lead and mentor a team of validation specialists, providing guidance and support throughout the validation lifecycle. Documentation: Oversee the preparation and review of validation documentation, including protocols, reports, and risk assessments. Risk Management: Conduct risk assessments and develop risk mitigation strategies to ensure product quality and compliance. Collaboration: Work closely with cross-functional teams, including Quality Assurance, Regulatory Affairs, and Engineering, to ensure validation processes are integrated into project plans. Training: Provide training to team members and stakeholders on validation processes, methodologies, and best practices. Compliance: Ensure compliance with relevant regulatory standards (e.g., FDA, EMA) and industry guidelines (e.g., GxP, ISO). Continuous Improvement: Identify opportunities for process improvements and lead initiatives to enhance validation efficiency and effectiveness. Audits and Inspections: Prepare for and support regulatory audits and inspections, providing necessary documentation and responses to inquiries. Qualifications: Education: Bachelors degree in Life Sciences, Engineering, or a related field; advanced degree preferred. Experience: Minimum of [8+ years] of experience in validation within regulated industries (pharmaceutical, biotech, medical devices, etc.). Technical Knowledge: Strong understanding of validation principles, methodologies, and regulatory requirements. Leadership Skills: Proven ability to lead and develop teams, fostering a collaborative and results-oriented environment. Analytical Skills: Excellent problem-solving and analytical skills, with a keen attention to detail. Communication Skills: Strong verbal and written communication skills, capable of presenting complex information clearly. Candidate Details Candidate Full Name (As per Passport): Contact Number: Email ID: Current Location: Work Authorization/Validity: Total Years of Experience: Relevant Years of Experience: Able to pass a (7 to 10) year background check and pre-employment drug test if required (Yes/No): Available Time Slot 1 (Skype/ Phone) Notice Period: LinkedIn Profile: Pay Rate Thanks & Regards Shaikh Mubashir Ahmed | US IT recruiter Direct : 281-699-0346 Email: [email protected] Keywords: information technology golang Idaho ValidationLead || Indianapolis,IN (onsite 5 days week) [email protected] |
| [email protected] View all |
| Mon Oct 07 21:52:00 UTC 2024 |