Designation : Executive / Sr. Executive - Quality Assurance

Role : Executive / Sr. Executive

Functional Area : Quality Assurance

Education : B.Pharm / M.Pharm / MSc

Industry Type : Pharma, Biotechnology

Experience : 8 - 12 Years

Compensation : Negotiable

Location : Dholka

Job Description

• Responsible to check & monitor day to day activities of QA department.
• Handle incidents, deviations and carry out the investigation.
• Identify, report and investigate any OOS/OOT, process change or unusual in production, QC and DAL.
• Well versed to carry out and maintain risk assessment and take necessary CAPA.
• Preparation or review of cleaning validation protocols, reports and monitoring activity as per procedure.
• Preparation, review and update of DQA & QA documents as per SOP.
• Preparation and updates of all the master lists of documents & equipments.
• Preparation and review of Batch Production Records (BPR) as per SOP.
• Organization of training of all the employees.
• Carry out internal audit, audit schedule and coordination of the audit in all departments.
• Carry out on line inspection as per QA guidelines.
• Well versed with handling & monitoring effectiveness of CAPA.
• Able to handle and investigate market complaints, return and recalls.
• Coordinate between Quality Control, production and other cross functional departments.