Associate Director Analytical lab

4 weeks ago

india Par Formulations Full time

Description

Responsible for life cycle management for laboratory instruments/ equipment & related software’s across all India sites. Responsible for planning & monitoring of capital budget requirement of quality department for all India sites. Ensure to develop rugged and robust CCIT methods for new injectable drug products. To oversight Analytical Lab, Digha operations & to support assigned functions for Global LTS. Site Lead & administration of Analytical Lab Digha, Mumbai for routine laboratory operations. Responsible to lead the team for harmonization of Global specifications & STP’s, protocol, reports & to support Global LTS function. Digha site lead for implementation of Lab Vantage, Empower 3 upgradation & to support other sites for these implementation. To harmonize laboratory instrument/ equipment qualification program across all ENDO sites. Authorized signatory for submission of documents pertaining to regulatory & Indian authorities. Responsible for review/ approval and guidance to incident, deviation, investigations, OOS, change control and CAPA. Representing site for management meetings and visits from external regulators. Responsible for life cycle management for laboratory instruments/ equipment & related software’s across all India sites. Responsible for planning & monitoring of capital budget requirement of quality department for all India sites. Ensure to develop rugged and robust CCIT methods for new injectable drug products. To oversight Analytical Lab, Digha operations & to support assigned functions for Global LTS. Site Lead & administration of Analytical Lab Digha, Mumbai for routine laboratory operations. Responsible to lead the team for harmonization of Global specifications & STP’s, protocol, reports & to support Global LTS function. Digha site lead for implementation of Lab Vantage, Empower 3 upgradation & to support other sites for these implementation. To harmonize laboratory instrument/ equipment qualification program across all ENDO sites. Authorized signatory for submission of documents pertaining to regulatory & Indian authorities. Responsible for review/ approval and guidance to incident, deviation, investigations, OOS, change control and CAPA. Representing site for management meetings and visits from external regulators. Direct oversight of laboratory functions for calibration, qualifications of laboratory instruments/equipment and establishment of departmental objectives consistent with company goals. Direct oversight of laboratory functions for review of analytical data. Responsible for resource management at Analytical Lab, Digha, Mumbai. Responsible to coordinate for internal & external audits. Responsible to take up additional responsibility allotted by the management and to fulfil the same. To implement and maintain quality systems in line with corporate business goals. To monitor and ensure compliance and regulatory requirements in day-to-day at Analytical lab, Digha, Mumbai. Review & evaluation of exiting systems, controls & identifying improvements to enhance compliance & efficiency. To provide safe laboratory environment for analytical activity. Responsible to ensure timely submission of laboratory analysis/study data for regulatory filing. Review & approval of all analytical protocols & reports. To plan & monitor yearly budget for site operations to meet departmental objectives. Responsible to identify & impart trainings to employees. Planning & implementation of skill enhancement, training & software’s. To maintain the analytical assets according to the requirement and use them appropriately. Education & Experience Master of Chemistry

Required Experience: 12-15 years of experience in Quality.

Commitment to Diversity, Equity, and Inclusion:

At Endo, our diversity unites and empowers us as One Team, and we are committed to cultivating, and valuing, each person’s unique perspective. We actively promote a culture of inclusion that draws strength from our broad spectrums of diversity, including race, ethnicity, religion, gender identity or expression, national origin, color, sexual orientation, disability status, age, and all our other unique characteristics, qualifications, demonstrated skills, achievements, and contributions, backgrounds, experiences, cultures, styles, and talents.

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