successfactors
Executive - QA
Lupin Limited
Sikkim, IND
Full-time
Senior · 6+ years experience
Onsite
Discovered 1 weeks ago
SAPQAMSeDMS
Free
Job Fit Check
Base Career helps you apply smarter for this job.
?%
Ready to ScanKey skills for this role
SAPQAMSeDMS
Role Overview
Compliance to the instructions given in Batch records of various products.
Ensuring the compliance of the SOPs and cGMP requirements at shop floor.
Ensuring no mix-ups, contamination and cross contamination of the products during all stages of manufacturing means of “Line Clearance” and continuous monitoring the process.
Performing “In-process Checks” at different stages of manufacturing for various products and ensuring the compliance.
“Sampling” at different stage of manufacturing or as per the requirement.
Stage wise review of batch records and compliances if any, to facilitate timely release.
Preparation, execution and compilation of process validation (Process performance qualification) and cleaning validation & cleaning verification.
Review of master batch manufacturing record and batch packing record in SAP
Active participation in execution of Qualification and calibration activity.
Periodic review and preparation of APQR.
Handling of CAPA, Change controls, OOS, OOT, Laboratory Incidence, Market complaint & Deviations through QAMS.
Co-ordination & execution of Self Inspection and compilation of self-inspection observations.
Active participation in investigation related to product / system failure.
Ensuring the awareness of cGMP and its requirement to the technicians/concerns through continuous interaction/SOP training.
Active Participation in Batch Release Activity.
Handling eDMS activities.
Active participations in all the IPQA activities.
Key Skills for This Role
SAPQAMSeDMS
Full Job Posting
Job Description
Compliance to the instructions given in Batch records of various products.
Ensuring the compliance of the SOPs and cGMP requirements at shop floor.
Ensuring no mix-ups, contamination and cross contamination of the products during all stages of manufacturing means of “Line Clearance” and continuous monitoring the process.
Apply for this job in 1 click
Skip the repetitive application forms
Install the Base Career Chrome Extension and autofill job applications across major job boards with your profile.
Trusted by over 500,000 job seekers on Base Career
More from this employer
More jobs at Lupin Limited
Officer – Production Mammalian
, IND
Junior
Job Description Job Title: Officer - Production Mammalian Job Description Downstream mammalian production maintaining cGMP and safety norms. Execution of DSP unit operation such as chromatography, TFF, VF, Virus inactiva
Discovered TodayView →
Associate Scientist :CRA
, IND
Senior
Job Description Supporting Project Management team for vendor due diligence and comprehensive assessments in collaboration with procurement and cross-functional stakeholders. Coordinate the execution of Statements of Wor
Discovered TodayView →
Computer Systems Validation Engineer
Somerset, USA
Mid
Header Job Description • Ensure compliance with regulatory requirements including 21 CFR Part 11, Electronic Records and Electronic Signatures, and applicable predicate rules, aligned with CSA (Computer Software Assuranc
Discovered TodayView →
Systems Engineer
Somerset, USA
Mid
Header Job Description Description: The IT Applications Systems Engineer - Manufacturing & Lab will own responsibility for pharmaceutical laboratory and GMP manufacturing IT systems. This role will engineer solutions to
Discovered TodayView →
Officer – Production Mammalian
, IND
Discovered Today
Associate Scientist :CRA
, IND
Discovered Today
Computer Systems Validation Engineer
Somerset, USA
Discovered Today
Systems Engineer
Somerset, USA
Discovered Today
Officer - Quality Control
, IND
Discovered 1 weeks agoFull-time
Senior Executive -QA
, IND
Discovered 1 weeks agoFull-time
Manager - Production
Tārāpur, IND
Discovered 1 weeks agoFull-time
Officer - Production Mammalian
Pune, IND
Discovered 1 weeks agoFull-time