Stelis Biopharma jobs; QA Validation Team Associates / Sr. Associates – B Pharmacy / M pharm

Stelis Biopharma jobs; QA Validation Team Associates / Sr. Associates - B Pharmacy / M pharm

Stelis Biopharma Hiring Notification for QA Validation Team
Qualification: B Pharmacy / M pharm

Designation: Associates / Sr. Associates

In the pharmaceutical industry, QA (Quality Assurance) and validation teams are responsible for ensuring that products and processes meet the required standards of quality, safety, and effectiveness. QA teams are typically responsible for establishing and maintaining quality standards, while validation teams are responsible for verifying that processes and systems meet these standards.

The specific responsibilities of a QA validation team may vary depending on the organization, but some common tasks that may be carried out by such a team include:

  • Reviewing and approving documentation for new or modified products and processes
  • Conducting inspections and audits to ensure compliance with regulations and standards
  • Testing products to ensure they meet specifications
  • Investigating and resolving quality issues
  • Providing training and guidance on quality and validation practices
  • Maintaining records and documentation related to quality and validation activities

In general, a QA validation team plays a critical role in ensuring the safety and effectiveness of pharmaceutical products, and is an important part of the overall quality management system of a pharmaceutical company

ELIGIBILITY

Experience: 3-8 years for Associate/Sr. Associates Experience

Location: Unit 2, Bangalore

Preferred Skill:

  • Ensure that all the cGMP equipment is validated in accordance with standard guidelines. Review and Execution of all Qualification/Validation activities of Equipments. Utilities and Areas in Stelis Biopharma Sites
  • Preparation, Execution, Review, and Compilation of Performance Qualification and Requalification protocols.
  • Support in preparation and review of SLIA, URS, CLIA, DQ, IQ, OQ, and 100 protocols and reports.
  • Preparation and review of Quality assurance validation departmental procedures in order to assure the established procedures are in line with national and international regulatory requirements.
  • To support cross-functional teams in handling Investigations for root cause analysis with regard to Deviations during Validation/Qualification.
  • Handling of Deviations, change controls and support in the closure of action items in order to check compliance with in-house and regulatory guidance.
  • Preparation and Execution of Aseptic Process simulations, Process Validation and Cleaning Validation protocols, and execution of the protocols.
  • To participate in Qualification/Validation activities executed on the shop floor.
  • Preparation and Review of Quality Risk Assessment Protocols and Reports of QA and Review of user department protocols. Handling of other responsibilities like document issuance (As applicable) assigned by Reporting manager and Head of the department
  • Preparation of Project Validation Plan and annual Validation/Qualification Plan.

Application Process: You are requested to send the updated resumes to nikhila.pakalapati@arcolab.com

 

Stelis Biopharma jobs; QA Validation Team Associates / Sr. Associates - B Pharmacy / M pharm
Stelis Biopharma jobs; QA Validation Team Associates / Sr. Associates – B Pharmacy / M pharm
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