17 April, 2022
§ Able to review Technology Transfer Documents like product development reports, vendor qualification reports, process performance reports and structure characterization reports.
§ Able to review the Analytical method validations & development reports for ICP-MS, ICP-OES, HPLC, GC, GCMS, LCMS, PSD, and XRD and ensuring method transfer from R& D to manufacturing sites by effective review mechanism and coordinate with CFT.
§ Able to lead the technology transfer requirements from R&D to manufacturing site from process, analytical activities to work rework once the product is sent to plant.
§ Able to give the requirements to be ensured in development as part of Quality by Design to avoid rework after technology transfer to production.
§ Able to guide team in fixing specifications of raw materials, starting materials and intermediates. To ensure specifications and standard procedures are reviewed and approved effectively.
§ Able to handle deviations, CAPA, OOS, Change control and planned changes at R&D.
§ Issuance of product codes, LNB’s, analytical raw data books and tracking them, reviewing to meet 27 CFR part 11 compliance at R&D.
§ Able to prepare SOPs & Standard Test Procedures and periodic revision of SOP’s as per GLP and cGMP requirement. Also able to prepare SOP’s for all the departments and respective formats with coordination of respective department HOD’s.
§ Facilitate internal audits to ensure cGMP compliance, review of calibration of analytical instruments.
§ Having through Knowledge in ICH guidelines.
§ Preparation of Batch Production records. (Trail BPR’s, Validation BPR’s and its Compilation Data).
§ Participate in mock audit prior to regulatory inspections and identifying the potential gaps and ensure timely closer of audit finding with effective coordination from auditee departments.
§ Conducting regular self inspections/inter unit audit as per schedule.
§ Coordinating with QA in vendor audit and handling on vendor qualification.
§ Responsible for review and suggest product developmental needs to comply with regulatory requirements.
§ Supporting to regulatory team in giving responses to various drug substance related deficiencies (carry over’s, evolution of genotoxic impurities, absence of elemental impurities, vendor evaluation) by coordinating with CFT.
§ Supporting to Regulatory Affairs department with respect to DMFs & comments received from Regulatory agencies.
§ Adequate Knowledge in identifying genotoxic impurities based on Muller alerts and knowledge of ICH M7.
§ Training and Qualification of employees. Review of analyst Qualification documents for approval in various techniques.
§ Internal audits, preparation of audit reports and immediate escalation of quality and compliance issues to head Quality and group leaders.
§ Able to coordinate with leads of different departments for “Peer review” mechanism to take the cross review inputs.
- Masters/Phd in Organic Chemistry with 7-15 years experience in DQA with 3-5 years experience in R&D, AR&D.
- Should be leading DQA in a leading company
- Have handled technology transfer for atleast 10-15 products or more till now.
- Should be able to work independently with minimal supervision
- Fast to adapt with quick turnaround time.
Apply through this Link