Assistant Manager, Quality Assurance

RXinsider LTD.; Hyderabad; On-site; INR 900,000 - 1,300,000; Full time

Job summary

RXinsider LTD. in Hyderabad, India, seeks an experienced QA professional to oversee SOP preparation and implementation and to monitor cleaning validation across manufacturing and warehouse areas.

The role involves active participation in qualification activities, cleaning validation protocol reviews, and APQR compilation. The candidate should hold a B.Pharm and have about 8+ years of relevant experience; a Master’s degree is preferred.

Qualifications

• B. Pharm is required.
• Master Degree (MS/MA) M.Sc. preferred.
• 8+ years of experience in pharma QC/QA.

Responsibilities

• Prepare and implement SOPs.
• Viable monitoring in clean area of manufacturing and warehouse as per the defined schedule.
• Participate in qualification, requalification, area qualification activities.
• Prepare Cleaning Validation Matrix, assessment of worse case products, cleaning validation protocol and reports, investigation of cleaning validation failures, PDE report review and assessment.
• Compile and review APQR reports and schedule.
• Handle Quality Management Documents like Change Control, Deviation; logging and closure of change control.
• Other tasks per direction of HOD.

Education

B. Pharm

Master Degree (MS/MA) M.Sc.

Job description

Description

JOB DESCRIPTION

• Responsible for Preparation and Implementation of SOP's.
• Viable monitoring in clean area of manufacturing and warehouse as per the defined schedule.
• Responsible for personnel monitoring.
• Responsible to participate in qualification, requalification, area qualification activities
• To prepare Cleaning Validation Matrix, assessment of worse case products, cleaning validation protocol and reports, investigation of cleaning validation failures, PDE report review and assessment and all relevant task related to cleaning validation.
• Responsible for Compilation and review of Annual product quality review (APQR) report and schedule.
• Activities other than that defined in the job responsibility are to be done, as per the requirements /instruction / guidance of HOD.
• Responsible to handle Quality Management Documents like Change Control, Deviation etc.
• Responsible for logging and closure of the change control related to document, equipment/instrument,facility /utility, process/product etc.

Education

QUALIFICATIONS

• B. Pharm B. Pharm - Required
• Master Degree (MS/MA) M.Sc. - Preferred

Experience

• 8 years or more in 8 - 10 Years

Specialized Knowledge: Licenses: