Job
Description
As an experienced and dynamic Validation Lead/Manager with 8-12 years of experience, you will be responsible for overseeing validation activities to ensure compliance with Good Practice (GxP) standards such as GLP, GCP, and GMP in the life sciences industry. **Key Responsibilities:** - **GxP Compliance:** Lead the validation team in ensuring adherence to GxP standards and maintaining compliance with regulatory requirements. - **Validation Strategy:** Develop and implement validation strategies, including risk-based approaches, to meet regulatory and industry standards. - **Team Management:** Supervise and mentor validation engineers/specialists, providing guidance on GxP, validation testing, and Computer System Validation (CSV) best practices. - **Computer System Validation (CSV):** Oversee the development, review, and approval of CSV documentation, including validation plans, protocols, reports, and risk assessments. - **Product Knowledge:** Utilize in-depth knowledge of life sciences and Healthcare products to guide validation efforts and support product implementation. - **Regulatory Compliance:** Stay updated on regulatory changes and ensure compliance with current regulations. - **Collaboration:** Work closely with cross-functional teams to align validation activities with project goals. - **Training:** Conduct training sessions for team members and stakeholders on GxP, validation processes, and CSV methodologies. - **Project Management:** Manage validation projects to ensure timely completion within scope and quality standards. **Key Skills:** - **Leadership and Management:** Proven experience in leading and managing validation teams with strong project management skills. - **GxP Compliance:** Extensive experience with GLP, GCP, and GMP standards and knowledge of regulatory requirements. - **Validation Testing:** Expertise in planning, executing, and documenting validation tests using various methodologies and tools. - **Computer System Validation (CSV):** Deep knowledge of CSV principles and documentation, including risk-based validation approaches. - **Life Sciences/Healthcare Product Knowledge:** Hands-on experience with systems like eQMS, eTMF, RIM, CTMS, Argus, RAVE EDC, or similar systems. **Qualifications:** - Bachelor's or Master's degree in a relevant field. - Minimum of 7 years of experience focusing on GxP, validation testing, and CSV. - Strong analytical and problem-solving skills. - Excellent communication and collaboration abilities. - Ability to lead, mentor, and motivate a team. Prepare estimations, collaborate with IT, Business, and cross-functional teams to ensure successful project outcomes.,
