Officer - Quality Assurance
Lupin
Date: 2 weeks ago
City: Remote, Remote
Contract type: Full time
Remote
Job Description
Ensuring the compliance of the SOPs and cGMP requirements at shop floor.
Performing “In-process Checks” at different stages of manufacturing and packing stages for various products during validation activity and ensuring the compliance.
Performing “Sampling” at different all the stages of manufacturing and packing.
Preparation, execution and compilation of process validation (Process performance qualification) and cleaning validation & cleaning verification.
Active participation in execution of qualification and calibration activity.
Review of master batch manufacturing record and batch packing record in SAP.
Active participation in investigation related to product / system failure.
Preparation of APQR & validation qualification protocol.
BMR, BPR & TDS Linking and result recording on SAP System.
Ensure the compliance of the SOPs and cGMP requirements in Qualification and validation.
To comply current EHS Management Systems of Site.
To comply all EHS Rules, Procedures, Guidelines, Policy, Practices, Requirements & Applicable Legal Compliances.
To carry out all assigned jobs in Safe Manner.
Ensure controls effectively on High Risk Activities / Significant Environmental Aspect & Impact.
Work Experience
3 years
Education
Graduation in Pharmacy
Competencies
Ensuring the compliance of the SOPs and cGMP requirements at shop floor.
Performing “In-process Checks” at different stages of manufacturing and packing stages for various products during validation activity and ensuring the compliance.
Performing “Sampling” at different all the stages of manufacturing and packing.
Preparation, execution and compilation of process validation (Process performance qualification) and cleaning validation & cleaning verification.
Active participation in execution of qualification and calibration activity.
Review of master batch manufacturing record and batch packing record in SAP.
Active participation in investigation related to product / system failure.
Preparation of APQR & validation qualification protocol.
BMR, BPR & TDS Linking and result recording on SAP System.
Ensure the compliance of the SOPs and cGMP requirements in Qualification and validation.
To comply current EHS Management Systems of Site.
To comply all EHS Rules, Procedures, Guidelines, Policy, Practices, Requirements & Applicable Legal Compliances.
To carry out all assigned jobs in Safe Manner.
Ensure controls effectively on High Risk Activities / Significant Environmental Aspect & Impact.
Work Experience
3 years
Education
Graduation in Pharmacy
Competencies
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