Quality Assurance and Control Specialist

20 hours ago

Bengaluru, Karnataka, India beBeePharmaceutical Full time ₹ 18,00,000 - ₹ 25,00,000
Job Title:

Quality Assurance and Control Specialist

This role is responsible for managing QC Mfg Systems at a leading pharmaceutical organization, ensuring the quality and integrity of products.

The successful candidate will be an expert in GXP Operations, with strong technical and leadership skills. They must have knowledge of data backup restore for GxP instruments, Administration of Quality Control systems, and GxP QC Systems - Administration, Security Policies, Configuration, Privileges, User Roles Management, Audit Trail Review, Date Time Setting, and User Management.

Key responsibilities include acting as administrators in Instrument Equipment connected application software in GxP Systems, performing data restore on users requests periodically, verifying it along with users, and maintaining their activities logs in line to SOP requirements.

Additionally, you will be responsible for system configuration, security policies implementation, ensuring system compliance state, and performing changes in instruments equipment connected applications software in GxP computerized systems as per change management procedure.

Furthermore, you will complete implementing the site's IT-related Change Controls, Deviations, Investigation Reports, CAPAs, and Audit Observations if any, and execute computer systems qualification and validation CSV activities in GxP systems as per Computer Systems Validation requirements.

To succeed in this role, you must have Graduation or Post graduation in Engineering or relevant fields, working experience in Pharmaceutical Life science industry, and excellent communication skills.

Responsibilities:

  • Manage QC Mfg Systems at a leading pharmaceutical organization.
  • Ensure the quality and integrity of products.
  • Act as administrators in Instrument Equipment connected application software in GxP Systems.
  • Perform data restore on users requests periodically.
  • Maintain their activities logs in line to SOP requirements.
  • Implement IT-related Change Controls, Deviations, Investigation Reports, CAPAs, and Audit Observations if any.
  • Execute computer systems qualification and validation CSV activities in GxP systems.

Requirements:

  • Graduation or Post graduation in Engineering or relevant fields.
  • Working experience in Pharmaceutical Life science industry.
  • Excellent communication skills.

What We Offer:

A challenging and rewarding career opportunity in a dynamic and growth-oriented organization.

A competitive salary package and benefits.

Ongoing training and professional development opportunities.

A collaborative and supportive work environment.

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