Roles and ResponsibilitiesWe have following requirement in QA Department1. IN PROCESS QA2.GOOD LAB PRACTICES- QA3.QUALITY MANAGEMENT SYESTEM4.VALIDATION5.VENDOR6.ANNUAL PRODUCT QUALITY REVIEWRoles and Responsibilities
Review of Master Manufacturing Formula for New and revision.
Review Formulation Development Report (FDR).
Review development report for Injectable products (Sterile solutions, Lyophilized powder,
Suspension and emulsion etc.)
Review in-house studies protocol (i.e. Reconstitution/ dilution study) and reports of R&D trial batches.
Review R&D batches stability data.
Review elemental impurities assessment/reports as per ICH Q3D for Injectable products.
New change control initiation and review and provide impact assessment for implementation of change control and verify the implementation of approved changes.
Review of deviation and conduct investigations to identify the root cause and propose CAPA as Excrequired.
Ensure the implementation of all CAPA.
Preparation of master formats, issuance as per relevant SOP's.
Review of scale-up protocol and report.
Review of Qualification activity for newly installed equipment's and instruments at R&D
Perform sampling of Finished Products, Active Raw material and excipients used in
manufacturing of pilot bio batches.
Preparation of Design trials for process and formulation in Design Expert Software and
preparation of stability data regression in Minitab software.
Having experience of development in dosage forms like Complex Injectable, Parenteral, Solid
Oral, Liquid, Semisolid, Suspension, Capsules, Ointment, Gel etc. and handled DQA requirement and internal audit for these areas of labs for compliance.
Study, Material Contact Study, Hold Time Study, Excipient Compatibility Study, Extractable
Leachable Study and Glass Delamination study) of Complex Injectable & Parenteral Products and implementation of DQA policies and SOPs in these areas as per requirement.
Employement Category:
Employement Type: Full time Industry: Pharma / Biotech Role Category: Process Control Functional Area: Not Applicable Role/Responsibilies: QA Officer