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Team Leader (Analytical Development)

8.00 to 10.00 Years   Mumbai City   24 Dec, 2020
Galentic Pharma (India) Pvt Ltd
Job LocationMumbai City
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaR&D / Product Design,Quality (QA-QC)
EmploymentTypeFull-time

Job Description

Job responsibilities:

  1. Independent handling of assigned projects of sterile ophthalmic and non-sterile dermatological products for regulated and non-regulated market.
  1. Close monitoring and review of analytical raw data generated for developmental, routine, stability analysis of lab scale batches, method validation and vendor qualification activities.
  1. Technical evaluation of assigned projects including guiding team in all kind of development and validation activities as per project requirements, trouble shooting and helping team for timely execution of project as per committed target completion date.
  1. Preparation and/or review of documents such as development approach paper,method development report, product specification and test procedures, methodvalidation protocols and report, method transfer protocol and reports, SOP, formats, CoA preparationetc.
  1. Review and/or approve Formulation Development documents including stability protocols, Drug-Excipient compatibility study protocols, QTPP and other as per project requirements.
  1. Review and/or approve documents and provide technical support to Rabale and Kandla QC team during method transfer and/or validation whenever applicable.
  1. Executeinstallation and qualification procedure for instruments and equipment and monitor calibration of all instruments and equipment as required.
  1. Co-ordination with service engineers for instrument and equipment maintenance and trouble shooting.
  1. Monitor audit trail of HPLC and other instrument software with periodic review of soft data and keep control on all required parameters.
  1. Close interaction with Formulation Development department for project management, technical discussion and work management of assigned projects.
  1. Monitor and support GDP, GLP, internal and external audit and compliance related activities within department to be in-line with QMS and USFDA requirement.
  1. Impart project specific and/or other related training to department and within team as necessary.
  2. Execute and monitor training of newly joined employee within team involving preparation of training modules, job description, review of assessment test papers etc. and ensure successful training procedure as per time schedule.
  1. Co-ordinate with supporting departments at H.O., R&D, Rabale, Kandla plant and vendor, customer, external lab, consultant etc. as and when required.
  1. Assess outside CRO for any analysis and monitor project related activities.
  1. Assess requirement for new instrument/equipment, prepare URS, obtain comparative data, and monitor installation and qualification procedure.
  1. Must have strong communication, technical writing and presentation skills.
  1. Effective planning, quality execution and organization of work is a must.
  1. Prior exposure to audits like USFDA, EU, TGA preferred.
  1. Any other duties as per organizational requirements.

Keyskills :
cropresentation skillscommunication skillsmethod validationtechnical writingformulation developmentusfdaursanalytical developmentaudit trailqmsanalytical methods developmentvendor qualification activitiesreview of documentsquality execution

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