AGM/GM- Analytical Method Validation
One of the fast-growing pharmaceutical formulation companies in Thane, that is currently very aggressive in the market and is recognized as one of the top 5 dossier filers in the industry.
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.
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
- Locations
- India
- Employment type
- Full-time
- Job location
- Thane

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