QA Assistant

Job description

Company Description

Briyosis Soft Caps Pvt. Ltd. is a privately-owned contract manufacturer of custom dietary supplement formulations. Based in Vadodara, India, we are an FDA registered and WHO-GMP certified company. With our high-efficiency encapsulation lines operating 24/7, we have the capability to produce over 3 billion soft-gels annually. Our 100,000 square feet facility encompasses production, laboratory, and warehousing space, and we adhere to FDA cGMP standards to ensure product quality and safety.

Skills & Job Descriptions -

Ø To issue the Batch Manufacturing Record, Equipment cleaning record, Logbooks, Analytical Report for raw material, finish product and packing material.

Ø Assistance in preparation of SOP of various departments/ preparation of draft SOPs.

Ø During plant round QA Executive to verify documents as per cGMP and GLP norms.

Ø Line Clearance activities for manufacturing and packaging before process starts.

Ø To issue the deviation form, Change control form, Out of Specification form, Customer complaint form, OOT form, investigation for etc. as per request from respective dept.

Ø Review and verification of Analytical and Batch Manufacturing Record and filing BMR. QA verification and release of finish product.

Ø To prepared documents & records and monitoring of activities as per SOPs

Ø Distribution, retrieval and control of SOPs, documents/records of all dept

Ø To participate the internal audits, customer audit, regulatory inspection.

Ø To Attend QR meeting as per schedule.

Ø To ensure data integrity as per procedure.

Ø To review manufacturing, store, QC activity.

Ø To prepare approved vendor list and maintain vendor qualification.

Ø Conduct traceability Activity.

Ø Preparation and maintain CAPA log.

Ø To ensure that deviations, product recall, return goods and customer Complaints, OOS, OOT by CAPA and Root Cause analysis are investigated, fill up of report and log the same.

Ø To collect data and prepare the annual product review

Qualifications –

• B.pharm/M.pharm/B.Sc/M.Sc
• Excellent communication and interpersonal skills
• Ability to work independently and within a team
• Experience working in a manufacturing environment is a plus

Job Type: फ़ुल-टाइम

Pay: ₹12,500.00 - ₹15,000.00 per month

Benefits:

• आने जाने में सहायता
• प्रॉविडेंट फ़ंड

Work Location: In person