PurposeAs a team leader for AMV, the candidate will be responsible to lead a team of more than 15 scientists, overseeing mainly the analytical method validation activities along with RM and PM verification and documentation.Replacement / New recruitment / Internal transferReplacementPosition / Job TitleAGMDepartmentAnalytical Method Development & Validation of Finished Dosage Forms. The candidate will also be responsible for API, excipients, PM evaluation and documentation.Reporting ToEx. Vice PresidentLocationThaneYears of Experience15 to 20 yearsDosage FormOSD / Nasal / Injectables / Ophthalmic / Topical
Job Responsibilities / Deliverables
- Accountable to lead the team for AMV of OSD, Nasal, Injectables, Ophthalmic and Topical dosage formulations. Also 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.
- Reply and justification to internal quality audits.
- Responsible for support to Regulatory and plant QC requirements.
- Skilled with Handling of Incident, change control associated with in department.
- In Support for Investigation of OOS, OOT in quality control department. Also 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 & Pre-Requisites
- M. Pharm / M. Sc. / Ph. D.
- Knowledge of management of spphisticated analytical instruments like HPLC, GC, LC-MS, GC-MS, ICP-MS etc.
- Awareness of regulatory guidances
- Knowledge of QMS
Additional notes
- Candidate is expected to work in any of the shifts based on the requirement (need based).
- Candidate is expected to visit external sites as per the project requirements.
