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
- 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.