212 Qualification Jobs - Page 9

Job Title: QA Assistant / Executive - API Industry Location: Kakinada, AP Company: Lyfius Pharma About Lyfius Pharma is 100% subsidiary of Aurobindo Pharma. Its largest API Unit of Aurobindo. Lyfius spread across 236 acres in Kakinada SEZ and it is second largest API manufacturing facility in ASIA. Qualification: M Sc / B Sc/ B Pharm Experience: 2 to 10 Years Job responsibilities: Quality Management System QMS Handling & Responsible for: Change Control, Deviation, Out of Specification, Market Complaint, Corrective and Preventive Action (CAPA) Annual Product Quality Review. Audit Compliance Report Preparation. Document Controller All document Issue, Review & Retrieval COA preparation BMR & BP...

Responsible for review and execution of SOP, Master BMR and BPR,Qualification document and Validation Document.IPQA activities on Injectable,CAPA,QA SOP's,ensure the cGMP compliance,To review the audit trail report.Calibration Preventive maintenance

Responsible for review and execution of SOP, Master BMR and BPR,Qualification document and Validation Document.IPQA activities on Injectable,CAPA,QA SOP's,ensure the cGMP compliance,To review the audit trail report.Calibration Preventive maintenance

Job Role : Manager Validation Location : Mohali Responsibilities : Build a cohesive Team to support Validation activity in A- 41 Mohali Location Collaborate for creating a robust CAPA program Equipment and facility Validation of A- 41 Mohali Location, along with site Specific teams, which includes preparation, review and execution of protocols, and Master Validation documents. Preparation, Review and execute protocols & reports in facility involving utilities, engineering, manufacturing operation & cleaning which shall include but not limited to HVAC, water, compressed air, process/packing equipment w.r.t. qualification & validation To ensure that all qualification and validation protocols i...

HIRING FOR FORMULATION UNIT - INJECTABLE/ OSD JOB DESCRIPTION AND EXPERIENCE: WORK LOCATION: Hetero Labs Limited, UNIT V & VI, Polleypally, Jadcherla, Mahabubnagar PRODUCTION(OSD) Experience: (02-07Years) Compression, Granulation, Coating, Capsule filling, Inspection PRODUCTION (INJECTABLE) Experience: (02-07Years) Autoclave, Compounding, filling, QMS, Vial Washing, Lyophilizer, Visual Inspection PACKING (INJECTABLE/OSD) Experience: (01-05Years) Blister Packing, Bottle Packing. QC & QC- Micro Experience: (02-07Years) HPLC, GC, RM,PM, Stability, IP/FP,MLT, Environmental monitoring, QA-INJECTABLE Experience: (02-07Years) IPQA, Validation, Qualification, CSV, AQA (QC & Microbiology) WAREHOUSE E...

1. Preparation of Annual/Periodic Product Quality Review (APQR/PQR) 2. Preparation of finished product specification (Tablet, External preparations & Injection) 3. Preparation of Protocol and Reports of PROCESS VALIDATION Batches. 4. Handling of Incidents, Deviation, CCP, OOS, OOT and Material Rejections 5. Issuing BARCODES for new Registered products in coordination with regulatory department. 6. Working Hands on MARKET COMPLAINTS and CAPA. 7. Preparation of Master Formula Record (MFR) and Preparation Of (SOPs). 8. Preparation of EQUIPMENT QUALIFICATION documents i.e. IQ, OQ, PQ protocol and Reports during Installation of New Instruments/ Equipments. 9. Identification of Hazard and Calculat...

Role & responsibilities protocol Preparation, review and execution for plant qualification preparation of process validation protocol, preparation and compilation of validation report co-ordinate for 3rd party calibration risk assessment preparation annual product review QMS, Change control, DEviation Preferred candidate profile B.Pharma/M.Sc with minimum 6-8 yrs experience in QA. candidate must have exposure of working in regulatory pharma plant.

We are hiring for a Green Field Projects at Amneal , Ahmedabad. Following is the JD : Key Responsibilities : Lead QA operations related to Qualification & Validation, including Cleaning Validation, Process Performance Qualification (PPQ), and Computer System Validation (CSV). Develop and implement Validation Master Plans (VMP), Contamination Control Strategies, and Quality Risk Management (QRM) frameworks. Ensure qualification and validation of manufacturing equipment, utilities, and computerized systems to meet regulatory requirements. Drive regulatory inspection readiness, acting as SME for audits including USFDA, EMA, ANVISA, and WHO. Implement and optimize QMS using a risk-based approach...

External Job Description Job title: Qualification & Validation Expert, Report Issuance Location: Hyderabad About the job Sanofi is a global life sciences company committed to improving access to healthcare and supporting the people we serve throughout the continuum of care. From prevention to treatment, Sanofi transforms scientific innovation into healthcare solutions, in human vaccines, rare diseases, multiple sclerosis, oncology, immunology, infectious diseases, diabetes and cardiovascular solutions. As a company with a global vision of drug development and a highly regarded corporate culture, Sanofi is recognized as one of the best pharmaceutical companies in the world and is pioneering t...

Qualification & Validation Specialist, Report Issuance Location: Hyderabad About the job Sanofi is a global life sciences company committed to improving access to healthcare and supporting the people we serve throughout the continuum of care. From prevention to treatment, Sanofi transforms scientific innovation into healthcare solutions, in human vaccines, rare diseases, multiple sclerosis, oncology, immunology, infectious diseases, diabetes and cardiovascular solutions. As a company with a global vision of drug development and a highly regarded corporate culture, Sanofi is recognized as one of the best pharmaceutical companies in the world and is pioneering the application of Artificial Int...

Role & responsibilities 1.Machinery Breakdown Management. 2. Operation and Preventive Maintenance. 3. SOP Preparation and Documentation. 4.Training and Development. 5.Equipment Qualifications. 6.Documentation and Data Management. 7.Material Coordination. Description: Attend or delegate personnel to attend machinery breakdowns promptly Monitor and verify the operation, preventive maintenance, and troubleshooting of process equipment. Responsible for qualifications (IQ, OQ, PQ), requalification, and revalidations of process equipment.

Preparation& Review of stability study protocols,reports, summery sheet for all the products ( General Injectable &OSD) cross functional with R &D,QA,Prodcution etc. ,GMP/SOP training QC Activities ADL/Oncology & General Block Qualification/issuance