API Quality Assurance - Assistant / Executive (Working in 3 shifts)

Job Title: API QA - Assistant / Executive

Location: Kakinada, AP

Company: Qule Pharma
About Qule Pharma is 100% subsidiary of Aurobindo Pharma. Its largest API Unit of Aurobindo.
Lyfius spread across 236 acres in Kakinada SEZ and it is second largest API manufacturing
facility in ASIA.

Quality Management System

Handling & Responsible for:

Change Control,

Deviation,

Out of Specification,

Market Complaint,

Corrective and Preventive Action (CAPA)

Annual Product Quality Review.

Audit Compliance Report Preparation.

Document Controller –

All document Issue, Review & Retrieval

COA preparation

BMR & BPR – Preparation & Review

Specification, Method of Analysis & Protocol & Report preparation for Finished product, Intermediate product, In-process, Raw material, Packing material.

Standard Operating Procedure (SOP) Preparation

Site Master Plan & Validation Master Plan Preparation

Technical Data Package (Tech Pack), Formula Master Preparation.

All Declaration Preparation for regulatory submission,

Customer Free Sample, Vendor Sample and Customer Query Related work.

Policies & system procedures preparation.

External Manufacturing & Toller documentation Control & Follow-up.

Training Calendar preparation and control.

Qualification / Calibration / Validation –

Responsible for all Calibration activity Internal & External and maintained the record.

Responsible for Equipment Qualification & Documentation control

Vendor Qualification and regular follow up for updated documentation by the supplier,

Process Validation Protocol & Report Preparation

Cleaning Validation Protocol & Report Preparation

Analytical Method Validation Protocol & Report Preparation

IPQA

Issue and control of SOPs, BMRs, BPRs, BCRs and also finished product label/product container seals /sealing of the containers as the part of IPQA activities.

Review BMRs, BCRs and analysis records before release of API.

Perform sampling of APIs, maintain its records and ensure the cleaning of sampling tools.

Provide line clearance at the time of product changes over.

Perform the documentation control activity at site.

Monitor/Maintain/Review of Records and Handling of controlled/Retained samples of Intermediates/Finished API.