Posted:15 hours ago| Platform: Linkedin logo

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On-site

Job Type

Full Time

Job Description

The ideal candidate will be responsible for implementing and maintaining quality systems, ensuring compliance with cGMP guidelines, conducting internal audits, reviewing batch records, and supporting regulatory inspections. This role demands strong documentation skills, a sound understanding of pharmaceutical quality standards, and the ability to work collaboratively across departments to uphold product integrity and safety throughout the manufacturing process.


JOB RESPONSIBILITIES:

1) Quality Risk Management

2) Batch Manufacturing Record preparation

3) Process Validation

4) Packaging Material Specification Preparation

5) APQR

6) Cleaning Validation

7) Batch card preparation

8) Dossier preparation

9) Change Control Management

10) Deviation Management

11) Endorse documents preparation

12) New drug application

13) Technology transfer


QUALIFICATION: M. Pharm


EXPERIENCE:


SKILLS REQUIRED:

Technical Skills

  • Knowledge of cGMP, GLP & GDP (Current Good Manufacturing Practices, Good Laboratory Practices, Good Documentation Practices).
  • Regulatory compliance understanding (USFDA, EMA, WHO, MHRA, etc.).
  • Quality control techniques – testing, validation, and calibration methods.
  • Process validation & equipment qualification (IQ, OQ, PQ).
  • Analytical skills – knowledge of HPLC, GC, spectroscopy, dissolution, and microbiological testing.
  • Deviation & CAPA handling (Corrective and Preventive Actions).
  • Change control & risk management.
  • Documentation accuracy – SOP writing, batch records, audit trails.
  • Internal audits & external audits readiness.
  • Data integrity principles (ALCOA+).

Soft Skills

  • Attention to detail
  • Problem-solving ability
  • Strong communication
  • Decision-making
  • Teamwork
  • Leadership
  • Time management & multitasking
  • Adaptability

Digital & Analytical Tools

  • LIMS / QMS software knowledge (e.g., TrackWise, MasterControl).
  • MS Office proficiency (Excel for data analysis, Word for SOPs).
  • ERP systems familiarity (SAP or Oracle in pharma).


COMPENSATION:


Aspiring candidates for Quality Assurance position are welcome to apply for the post. Interested & Eligible person may share their resume in - atrayee.mandal@mendine.com

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