Job Title: QA Executive / Sr. Executive / QMS Document Controller

LOCATION:                  Ahmedabad

REPORTS TO:              Quality Manager - India

WORKPLACE TYPE: [On-site / Hybrid / Fully Remote] - On-site

The QA Executive / Sr. Executive / QMS Document Controller is responsible for

[Quality Assurance, Quality Management System & Document Controller in Quality Department] 

Salary Range : Around 50,000/-  or  20% hike in current salary.

Core Responsibilities:

• 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

Desired Requirements:

• Degree [M.Sc. in Chemistry / B. Pharm / M. Pharm]
• Work experience [ Minimum 5 to 7 years of total work experience in the field of Excipient & API Manufacturing, Formulation industry]
• English fluency, both written and spoken
• Well versed in Quality tools and PPT preparation.