Mohammed Naeem Shaikh

Group leader in Analytical development Laboratory at Cipla Pharmaceuticals LTD

• India - Mumbai
• November 2002 to July 2016

 Daily Planning, Work Allocation for team members for analytical support.
 Data Review, Reporting of results and review of method development reports.
 Review and issuance of STP and Specification for API, FP and Excipient to respective plant location.
 Guiding the team to develop rugged and robust analytical methods & assist team in trouble shooting for HPLC, Disso and other lab activities.
 System development for smooth operation and errorless lab activities.
 Compilation of R&D batches stability & development data and updating them to HOD.
 Testing of APIs, excipients, intermediates and finished products by GC and HPLCI for method trouble shooting, transfer and validation purposes.
 Setting & Developing strategies & Objectives.
 Support R&D development portfolio working with project teams to establish companys quality procedures, standards and specifications (API and Drug Product)
 Coordinating with various functions, ensuring optimum utilization of the resources & Implementing & maintaining the quality system.
 Identify basic technical issues, atypical or out-of-specifications test results, instrument malfunctions and methodology problems, and participate in investigations for resolution and correction.
 Communication and coordination with regulatory dept. for regulatory queries before and after filing w.r.t method validations.
 Possesses of planning to solve Analytical related issues.
 Sound Knowledge of Audit preparation.
 Power point presentation of the product at different stage gate.
 Assisted part method validation & full Validation of the product as per QCP.
 Setting Impurity limits as per ICH Guidelines
 Analytical Tech transfer to respective location.
 Training to newly joined analysts.