Sperton CV-Holding

We are looking for a senior professional (AGM/GM level) with 1520 years of experience in Analytical Method Validation for regulated markets. The role involves leading API and excipient method validation across multiple dosage forms and managing a team of 30, including three senior managers. The ideal candidate must be technically strong, experienced in US/EU compliance, and hold an M. Pharm, M.Sc., or Ph.D. Role & responsibilities: Accountable to lead the team for AMV of OSD, Nasal, Injectables, Ophthalmic and Topical dosage formulations. Responsible for RM & PM characterization and documentation. Generate qualification/validation projects and associated documentation in support of the analytical activities performed ensuring compliance requirements are maintained. Represent as the subject matter expert for lifecycle management of analytical assays, equipment and materials including in process samples and finished products. Responsible for answering the analytical queries before and after submission with regulatory department and external regulatory authorities. Review of DMF for outsourcing API and preparation and follow up of review reports. Responsible for setting of product specifications and Methods, and Preparation of various justifications to internal quality audits. Responsible for support to Regulatory and plant QC requirements. Skilled with Handling of Incident, change control associated with in department. Support for Investigation of OOS, OOT in quality control department. Periodically perform internal Audit and carry out Internal quality compliance Training. Exceptionally well organized and detail-oriented with capability to meet deadlines. Holds competencies in implementing various quality standards and techniques for improving the project operations along with cost savings. An effective communicator with excellent relationship building & interpersonal skills; strong analytical, problem solving & organizational capabilities. Coordinates findings with the team to generate conclusions. Coordinates system maintenance and calibrations to ensure minimum downtime. Ensure GLP compliance in the laboratory and to make lab audit ready all the times. To provide any technical support to plant and ensure all QC required documents are provided in time. To discuss with formulation leads on all project related activities to ensure timely delivery of the products. To ensure timely availability of material budget for initiation of product development and validation. To prepare and review the Capex for analytical department. Qualification & Prerequisites : Be technically strong and have hands-on experience in regulated markets such as the US. Possesses excellent people management and leadership skills. Qualification : M. Pharm / M. Sc. / Ph. D. Knowledge of management of sophisticated analytical instruments like HPLC, GC, LC-MS, GC-MS, ICP-MS etc. Awareness of regulatory guidance's Knowledge of QMS