Officer QMS Documentation

QMS documents initiation and review: QMS documents initiation for QC. Responsibilities SOP preparation, review and tracking till closing the CCF. Initiation of Change control for departmental activity, to perform the assessment of departmental / cross functional department CCF, to perform impact assessment. To ensure the closure of CCF within the...

VIal PackingAmpoule PacknigVisual InspectionVIal PackingAmpoule PacknigVisual InspectionQMS   Documentations. 

To initiate and perform the QMS activity. Handling Deviations, CAPAs and Change Controls. Performing IQ, OQ and PQ activities of vial and ampoule filling machine. To prepare the SOPs, BMR, Protocols and documents related to the Parenteral production facility. Preparation for audit related documentation and maintaining area. Review of BMR and other...

Responsibilities:Ensure compliance with QMS protocols in production and packing areas.Review and maintain batch records, SOPs, and documentation as per USFDA standards.Support deviation investigations, CAPA, and change control processes.Coordinate with cross-functional teams to uphold GMP and regulatory requirements.Key Skills:Knowledge of QMS and GMP in...

Sr. No.Responsibilities Parenteral Packing1.0 Equipment and area qualification activity:1.1To perform the equipment qualification (SAT/ IQ/ OQ / PQ) like labelling machine, Blister machine, Cartonator machine, Track and trace system, Visual Inspection and Leak Testing Machine, Stretch Banding Machine and Weighing Balance as per VMP and approved...

QMS Implementation & MaintenanceEnsure compliance with ISO 9001:2015 requirements across all departments.Assist in preparing, reviewing, and controlling QMS documentation (SOPs, Work Instructions, Formats, Manuals).Coordinate Internal Audits, Management Review Meetings (MRM), and facilitate closure of NCs (non-conformities).Monitor effectiveness of processes...

Job Description About Omega QMS: Omega QMS is India's leading consultancy organization providing end-to-end solutions inconformity assessment,regulatory compliance, andmarket access. Our expertise spansBIS Certification(Domestic, Foreign, and Scheme X for machinery and electrical equipment),BIS Registrationfor electronic and IT products,BEE approvals,TEC...

Responsible for FP/IP/Stability section activityTimely execution  of Receipt , Analysis and release of FP/IP/Stability samples.Timely execution of  Work allocation,Analytical data review,QMS activity etcMaintain discipline in Laboratory.Impart required training to all team member.Follow the HOD instruction for proper lab management.Timely submission of...

To initiate and perform the QMS activity.•Handling Deviations, CAPAs and Change Controls.•Performing IQ, OQ and PQ activities of vial and ampoule filling machine.•To prepare the SOPs, BPR, Protocols and documents related to the Parenteral packing facility.•Preparation for audit related documentation and maintaining area.•Review of BPR and other...

Department: Production QMS Designation: Officer to Executive Experience: 3 to 6 Years Location: Bavla, Ahmedabad Key Responsibilities: ✅ Injectable Production Activities Carry out and monitor day-to-day manufacturing of injectable products (aseptic or terminal sterilized). Follow batch manufacturing records (BMRs) and SOPs during production. Coordinate...