Assistant General Manager

We are looking for a senior professional (AGM/GM level) with 15-20 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.

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.

Qualifications

• 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

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