Veedo Lifesciences is hiring an experienced professional for the position of Auditor – Analytical QA at its facility in Peenya, Bangalore.
Candidates with 5–8 years of experience in analytical quality assurance, analytical characterization, and pharmaceutical or biosimilar development can apply.
The role involves reviewing analytical studies, auditing technical documentation, ensuring data integrity, and maintaining compliance with applicable regulatory requirements.
Interested candidates with relevant experience in analytical characterization techniques and quality assurance can submit their updated CV by email.
Company Overview
Veedo Lifesciences is recruiting for an Auditor – Analytical QA position focused on analytical quality assurance and biosimilar development activities. The role requires experience in reviewing analytical characterization studies, technical reports, and supporting documentation.
Veedo Lifesciences Recruitment: Job Role & Responsibilities
Auditor – Analytical QA
The selected candidate will support analytical quality assurance activities related to analytical characterization studies and biosimilar development.
Key responsibilities include:
- Performing QA reviews and audits of analytical characterization studies supporting biosimilar development.
- Reviewing study protocols, reports, raw data, and supporting documentation for compliance with GLP principles where applicable, ALCOA+ principles, internal procedures, and data integrity requirements.
- Ensuring compliance with applicable regulatory requirements, including FDA, EMA, and relevant ICH guidelines such as Q5E, Q6B, Q2(R2), Q9, and Q14.
- Reviewing complex analytical characterization data, including HOS, SPR, NMR, FTIR, CD, DSC, DLS, peptide mapping, glycan profiling, and comparability assessments.
- Conducting internal audits of CMC R&D functions and participating in sponsor audits, regulatory inspections, and due diligence audits.
- Reviewing analytical comparability assessments and associated statistical evaluations to support scientific validity and appropriate biosimilarity conclusions.
- Providing QA guidance and support during biosimilar development activities and regulatory filing programs.
- Reviewing and approving analytical study protocols, validation protocols and reports, characterization reports, technical reports, change controls, deviations, OOS/OOT investigations, CAPAs, and risk assessments.
Eligibility & Qualifications
Educational Qualification
The recruitment announcement does not specify a mandatory degree or particular educational qualification. Candidates should have relevant experience in analytical QA and pharmaceutical or biosimilar development.
Experience Required
- 5–8 years of professional experience.
- Experience in analytical characterization studies and quality assurance audits.
- Familiarity with regulatory compliance and data integrity requirements.
Required Technical Skills
- Analytical characterization techniques, including HOS, SPR, NMR, FTIR, CD, DSC, and DLS.
- Peptide mapping and glycan profiling.
- Analytical comparability assessments.
- Knowledge of ALCOA+ principles and GLP, where applicable.
- Familiarity with FDA, EMA, and relevant ICH guidelines.
- Documentation review, audit execution, deviation management, and CAPA review.
Location & Salary
- Designation: Auditor – Analytical QA
- Location: Peenya, Bangalore
- Experience: 5–8 years
- Salary: Not specified in the recruitment announcement.
How to Apply
Interested candidates can send their updated CV to the recruitment email address provided below.
Email: Mahendra.t3705@veedolifesciences.com
Candidates should highlight their analytical QA experience, audit exposure, regulatory knowledge, and analytical characterization expertise in their CV.
Frequently Asked Questions
1. Which company is hiring for the Auditor – Analytical QA position?
Veedo Lifesciences is hiring for the Auditor – Analytical QA role.
2. How much experience is required?
Candidates with 5–8 years of experience are sought for this position.
3. Where is the job located?
The position is based in Peenya, Bangalore.
4. What are the main responsibilities?
The role includes analytical QA audits, documentation review, regulatory compliance, analytical characterization review, and support for biosimilar development.
5. Which analytical techniques are mentioned?
The recruitment announcement lists HOS, SPR, NMR, FTIR, CD, DSC, DLS, peptide mapping, and glycan profiling.
6. How can candidates apply?
Candidates can email their CV to Mahendra.t3705@veedolifesciences.com.
Job Summary
| Category | Details |
|---|---|
| Company | Veedo Lifesciences |
| Vacancies | Auditor – Analytical QA |
| Required Education | Not specified in the recruitment announcement |
| Experience | 5–8 years |