Executive - QA
Job Description
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.
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.
Work Experience
6-9 years
Education
Graduation in Pharmacy
Competencies
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.
Work Experience
6-9 years
Education
Graduation in Pharmacy
Competencies
More Info
Job Type:
Industry:
Function:
Employment Type:
Key Skills
Change controls
Self Inspection
In-process Checks
Process performance qualification
QAMS
OOT
Line Clearance
Market complaint
Laboratory Incidence
Qualification and calibration activity
APQR
About Company
Skills:
Cleaning Validation, DS DP shop floor QA activities, Process Validation, Cgmp, Qms, documentation control, BMR review, in-process controls, Regulatory Requirements
Skills:
validation qualification documentation, Deviation CAPA Change Control, self-inspection, Document Control, Gmp, BMR BPR review, regulatory customer audits, Quality Management System, GMP GDP compliance, WHO-GMP Schedule M, Qa Documentation, SOP preparation
Skills:
statistical data analysis , SAP, Ms Office, IMS Integrated Management System, Testing of Concrete Trials, Liquid Admixture
Skills:
Empower, data integrity, Cgmp, ALCOA principles, Lims, analytical method transfer, Glp
Skills:
Regression Testing, quality assurance, Qualification, PQ, OQ, Gmp, IQ, Iso, Fda, Equipment Cleaning, Validation, Qms, Data Analysis, Documentation Skills