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QA Executive / Sr. Executive / QMS Document Controller

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Gender
Male
Experience
5 - 7 Years
Location
GANDHINAGAR
Salary
Rs. 40,000 - 50,000 Thousands INR
Key Skill
APIs
Qualification
PHARMACY
Industry
Pharmaceuticals, Biopharmaceuticals, Bulk Drugs
Job Function
Pharma/ Biotech/ Helthcare/ Medical/ R&D
Role
QA Executive / Sr. Executive / QMS Document Controller

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.

 

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Contact Person Name
Sneha kumari
Contact Email
recruitment@cosmosgroup.in
Contact Mobile No.
9909922628



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