BioTalent Search Private Limited
Location
Pune | India
Job description
Job Description: Validation Manager
Position Overview: We are currently seeking a Validation Manager for a pharmaceutical project on behalf of our client at the Thailand Project Site location. The Validation Manager will play a crucial role in ensuring the compliance and effectiveness of validation processes within the project. Key Responsibilities: Develop and implement validation strategies, protocols, and procedures in accordance with regulatory requirements and project specifications. Oversee the validation activities related to formulations projects, including Oral Solid Dosage (OSD) and Injectable products. Ensure the validation of water systems and utilities meets industry standards and project requirements. Collaborate with cross-functional teams to plan and execute validation activities, including equipment qualification, process validation, and cleaning validation. Review and approve validation documentation, including protocols, reports, and deviations, to ensure accuracy and compliance. Provide guidance and support to project teams on validation best practices and regulatory requirements. Monitor validation schedules and budgets to ensure timely completion of activities within project constraints. Participate in regulatory inspections and audits, addressing validation-related inquiries and findings as needed. Requirements (must have): Experience: The ideal candidate should have over 10 years of experience in pharmaceutical validation, with a proven track record of success in similar roles. Qualification: Minimum Bachelor's degree in Engineering (BE/BTech compulsory). Additional qualifications in validation or quality assurance are desirable. Specialization: Strong exposure to Formulations Projects (OSD and Injectables), Water System, and Utility Validation is essential. Joining: Candidate must be available for immediate joining to meet project timelines and requirements. Key Skills: In-depth knowledge of validation principles, practices, and regulatory requirements (e.g., USFDA, WHO, EMA, ICH). Excellent communication and interpersonal skills, with the ability to collaborate effectively across diverse teams. Strong analytical and problem-solving abilities, with keen attention to detail. Proven leadership skills, with the ability to motivate and mentor team members. Adaptability and flexibility to thrive in a fast-paced, dynamic environment. This position offers an exciting opportunity to contribute to the success of a pharmaceutical project and make a significant impact on product quality and patient safety. If you meet the requirements outlined above and are passionate about validation excellence, we encourage you to apply for this role.Job tags
Salary
