Ind-Swift Limited - Jawaharpur, Derabassi is the Ace unit of Ind-Swift Limited, was created in the year 2005 with an aim to globalize the Ind-Swift brand for finished dosage forms. We are a 100% Export Oriented Unit dealing in regulated markets having approval like MHRA, TGA & GLC etc.
OPEN POSITIONS IN QUALITY ASSURANCE 100% EOU Formulation Site.
Sr. Executive / Assistant Manager
Job Description
• Handling of change controls
• Document amendment proposal
• Batch release and rejection
• Performing of risk assessment
• Performing self-inpection EXPERIENCE
Experience : 8-12 years
Executive / Assistant Manager
Job Description
• Review of PQR (Product Quality Review)
• Issuance of approved shade card Handling of change control
• Issuance & review of Document Amendent Proposal
• Handling of Risk Assessment
• Impact assessment & required implementation of regulatory update
• Approval of documents i.e., SOP index. Formats, etc
• Coordination with Regulatory Affairs for dossier compilation
• Handling of vendor approval
Experience : 6-12 years
Executive / Assistant Manager
Job Description
• Review and approve Analytical Data Packages for QC stability studies
• To get CAPA done for observed deficiencies
• Approved auditor for performing self-inspection
• Responsible for release/rejection of raw, packaging and miscellaneous materials
• Responsible for reviewing and approving batch analytical documents including starting material, in-process sample, finished product, and stability data worksheets
• Responsible for conducting OOS/OOT investigations for finished product, raw material, stability samples, and packing material in accordance with approved QA SOPs
• Maintaining and reviewing analytical review findings trends
Experience : 8-12 years
Note : Only MHRA, EU GMP & USFDA exposure candidates will be entertained.
Kindly send your CVs to the following addresses :
hr.gbu@indswiftlabs.com
Ind-Swift Ltd., Off. NH-21, Vill. Jawaharpur, Derabassi, Distt. Mohali, Punjab -140507
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