Regulatory Affairs Officer

Working knowledge of cGMPs or other FDA/international regulatory standards. Knowledge of ICH guideline & ISO 9000 standards. ·Hands on experience and knowledge of engineering – Utility Function as operation and maintenance, documents and cGMP and GEP compliance.·Hands on experience of various Utilities as, Boiler, Thermopack, Chilled brine system chilled...

Job Title: Sr. Executive - Quality Compliance (Supplier Quality Assurance)Department: Quality ComplianceReports to: Quality Compliance Manager Location: AnkleshwarPosition Type: Full-timeQualifications and Experience:Education: B.Pharm / M.Pharm / M.Sc in Chemistry, Biotechnology, or related field.Experience: Minimum  6–8 years of experience in Quality...

• Knowledge of GMP / GDP regulations in pharma industry.• Familiar with ERP / Tally / Inventory management software.• Strong organizational and problem-solving skills.• Ability to handle audits and regulatory inspections.

Role: Quality Operations SpecialistMANDATORY REQUIREMENTSGraduated / post-graduate in Pharmacy/Medicine or Chemistry/Biotechnology5 to 8 years minimum experience in Quality or Regulatory AffairsExperience obtained in pharmaceutical manufacturing sites (+3 years).Knowledge of stability regulations and its application to the industrySkilled in the usage of IT...

Job description:Computer system validation & QA-IT (Process) Related activity.Review of Qualification and Re-Qualification protocol & report.Review of Preventive Maintenance & Calibration records.Review and approval of critical consumable items.Monitoring of engineering & utility services: Current layouts of facility, building, man & material flow, HVACs,...

Position: Junior Officer / Chemist Quality Control (QC)Industry: Pharmaceutical – API ManufacturingLocation: Ankleshwar, GujaratDepartment: Quality ControlExperience: Minimum 2 Years (Pharma – API Experience Mandatory)No. of Positions: 2Job Description:We are seeking a detail-oriented and experienced Junior Officer / Chemist – QC to support our API...

Job Title:Assistant Manager - Quality Assurance, ChemistryEducation / ExperienceM. Sc. Industrial Chemistry / B. Pharma / M. Pharma having 8 to 10 years in API industry with related experience in the following fields: QA, Manufacturing & GMP.KEY ACCOUNTABILITIES1.Quality Management/Continuous ImprovementManagement and control of SOPs, Master documents,...

Roles and ResponsibilitiesDevelop formulations for solid oral dosage forms (tablets) and liquid orals.Conduct formulation research development, stability studies, and analysis to ensure product quality.Prepare trial batches of formulations and document them accurately.Collaborate with cross-functional teams to resolve formulation-related issues.Ensure...

JOB DESCRIPTIONPosition: Quality Alert ExpertMANDATORY REQUIREMENTSGraduated / Post-graduate in Pharmacy/Medicine or Chemistry10 to 12 years minimum experience in Quality or Regulatory AffairsExperience obtained in pharmaceutical manufacturing sites (+5 years).Skilled in the usage of IT tools (for example: Trackwise, Share/DrugTrack, eDMS), .English...

Perform Daily Routine analysis as requested by Synthesis lab and Pilot lab.Handing, maintaining and troubleshooting of Analytical/scientific instruments (Weighing balances, HPLC, GC, KF, IR, pH meter. etc)Perform Wet Analysis, titration and all other test for preformulating analytical data evaluation.Perform Partial Validation and Check Compatibility of...