Specialist - Quality Operations

Job Description:

Responsibilities

• Coordination and management of analytical method transfers and stability studies. Compilation of data reports
• Life-cycle management of analytical methods, including control of method performance, pharmacopoeia and health authority compliance and definition of method improvements. Handling of deviations, investigation, OOS/OOE/OOT cases as well as changes and complaints
• Work on various Labware LIMS workflows including various modules like Lot management, stability management, instrument interfacing, reagent management.
• Management of Master data in Labware LIMS and perform migration of LIMS records. Execute validation of configured workflows and calculations relevant to LIMS modules
• Perform test run/dry run in Labware LIMS for various workflows.
• SAP master data management: Maintenance of master data, creation of Q-info records and other SAP related activities.
• Collect, transcribe and/or compile data from various repositories (SAP, LIMS, external COAs)
• Trend and report all QMS elements as per the request
• Monitor, trend and report Health Safety and Environmental parameters
• Implementation of GMP requirements. Compilation and Review of documents (analytical protocols and reports, annual performance quality reports, ongoing process verification reports, registration documents (Common Technical Document modules).
• Perform activities of a Quality Control expert as defined by the respective sit and support regulatory requirements – routine queries, Chromatogram requests
• Create and review GxP documents including SOPs, working procedures, trend reports, qualification reports and technical investigations, as and when needed

Qualification & Expeirnece

• Pharmacy/ Science/ MBA / M.Tech/MSc /Engineering/ equivalent from a reputed institute
• Min 6 years of experience in Quality Assurance, Regulatory or in the manufacturing of pharmaceutical drug substances/ products/ medical devices
• GxP knowledge, Basic IT knowledge