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 . 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 detailoriented 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 handson 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 LCMS GCMS ICPMS etc.
• Awareness of regulatory guidances
• Knowledge of QMS