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Quality Assurance Manager And Documentation Specialist

2 months ago

Bareilly, India Bombay Pharma Equipments Full time
Company Overview

Bombay Pharma Equipments, situated in Vasai Virar, stands as India's prominent pharmaceutical equipment manufacturing entity. Since 1984, we have specialized in crafting Zero Hold Up Filter Press and Whole Granulation Line solutions.

Role Description

We seek a highly motivated and experienced Quality Assurance Lead and Documentation Specialist to join our team on a full-time, on-site basis. This pivotal role will be responsible for ensuring the utmost quality of incoming materials, meticulously requesting mandatory documentation from suppliers, and subsequently authorizing Goods Received Notes (GRNs).

Furthermore, the incumbent will play a crucial role in conducting comprehensive Internal Factory Acceptance Tests (FATs) of our equipment, thereby assuming accountability for quality assurance and granting dispatch clearance.

The ideal candidate will possess expertise in preparing essential documentation, including Design Qualification, Installation Qualification, Performance Qualification, Operational Manual, and Cleaning Qualification. These documents will be diligently submitted to customers, along with any additional documentation they may require.

Key Responsibilities

- Oversee the quality assurance of incoming materials, requesting mandatory documentation from suppliers and issuing GRNs accordingly.
- Conduct thorough Internal FATs of equipment and provide dispatch clearance, ensuring adherence to stringent quality standards.
- Prepare and submit critical documentation, such as Design Qualification, Installation Qualification, Performance Qualification, Operational Manual, and Cleaning Qualification, to customers.
- Promptly address any additional documentation requests from customers.