Job Description:

- Responsible for operations of advance analytical instrument (LCMS, GCMS and ICPMS)

- Analytical method validation for finished product, Raw Material and Intermediates as per the requirements and successfully transfer the analytical methods to other sites.

- Evaluation of the batch records / Analytical documents / Qualification documents.

- Periodical review of Audit trial and verification of system generated electronic data's.

- Conducting preventative maintenance, calibration and troubleshooting of analytical instruments as required

- Compiling data for documentation of test procedures and preparing protocols, reports and SOPs; reviewing data obtained for compliance to specifications and reporting abnormalities

- Handling of Deviations - Change controls - OOS - as well as in released products - Market complaints - Risk assessment- Impact Study - VMP.

- Monitoring the testing / re-testing of incoming and in-process samples following correct and proper protocols outlined by SOP's and references; ensuring the use of analytical instruments such as GCMS, LCMS, ICPMS,HPLC, GC and calibration instruments for measuring specs

- To identify future requirements of Equipment's / Instruments and prepare Capital expenditure form to ensure that the facility has the technical and operational capacity to handle current and future testing needs of the laboratory.

- Ensuring process improvements on analytical methods & procedures to streamline efforts & reduce preparation time

- People Management: Handling team members, mentoring, training

Candidate Requirement:

- 15 yrs experience in Pharma Industry with minimum 5 years of experience in the Analytical R& D space

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