Looking for an exciting career opportunity in Quality Assurance within the life sciences industry? Precision Medicine Group is hiring a Quality Assurance Specialist III for its Bangalore, Karnataka location. This opportunity is ideal for experienced professionals with a strong background in GxP quality systems, clinical research, data integrity, and regulatory compliance. If you have experience in QA audits, computerized systems, and quality oversight, this role offers an excellent opportunity to work with a global organization.
Job Overview
Position Name: Quality Assurance Specialist III
Company Name: Precision Medicine Group
Job Location: Bangalore, Karnataka, India
Employment Type: Full Time
Experience Required: Minimum 4 Years
Qualification: Bachelor’s Degree or Master’s Degree in Life Sciences, Pharmacy, Biology, or Chemistry
Key Roles & Responsibilities
The selected candidate will be responsible for maintaining quality standards across GLP and GCLP studies while ensuring compliance with internal SOPs and global regulatory requirements.
Major responsibilities include:
- Prepare study-specific audit schedules before First Patient In (FIP).
- Develop audit plans and prepare evidence-based audit reports.
- Review controlled study documents and verify SOP compliance.
- Review clinical protocols, sample analysis protocols, and amendments.
- Ensure proper closure of quality events before data reporting.
- Perform QA review of experiment records and batch records.
- Review data tables, listings, and summaries for traceability and consistency.
- Verify sample ID reconciliation and protocol compliance.
- Apply ALCOA+ data integrity principles during electronic data reviews.
- Support computerized systems audits and document reviews.
- Prepare audit checklists and audit documentation.
- Conduct data integrity assessments of paper and electronic records.
- Evaluate audit trails, metadata, system validation, and security controls.
- Identify data integrity gaps and system vulnerabilities.
- Assist in training QA personnel when required.
- Support customer, regulatory, and notified body audits.
- Provide backup support to other Quality Specialists.
Required Qualifications
Applicants should possess:
- Bachelor’s Degree or Master’s Degree in Life Sciences, Pharmacy, Biology, or Chemistry.
- Minimum 4 years of experience in a GxP life sciences environment.
- CRO experience will be an added advantage.
- Strong understanding of:
- ICH-GCP (E6 R2/R3)
- FDA 21 CFR Part 11
- EMA / EU CTR / Annex 11
- GCP, GMP, GLP and GCLP frameworks
- Experience with LIMS and computerized quality systems.
- Knowledge of Computer System Validation (CSV) and Computer System Assurance (CSA).
- Ability to interpret raw data and reported data discrepancies.
- Strong Microsoft Office skills.
- Excellent written and verbal communication skills.
- High attention to detail and ability to work independently.
Preferred Certifications
- ASQ Certified Quality Auditor (CQA)
- ISO 9001 Lead Auditor
- ISO 13485 Lead Auditor
- GxP Lead Auditor Certifications (CQI/IRCA)
- Clinical QA Certifications (CCQAP)
Salary & Benefits
Estimated Salary: ₹10,00,000 – ₹16,00,000 per annum (Expected range based on similar Quality Assurance roles, experience, and market standards.)
Additional benefits may include:
- Competitive compensation package
- Career growth opportunities
- Exposure to global clinical research projects
- Professional development and training
- Collaborative international work environment
Why Join Precision Medicine Group?
Precision Medicine Group is a globally recognized organization dedicated to advancing healthcare through innovation, quality, and scientific excellence. Employees get the opportunity to work on high-impact clinical research programs while contributing to maintaining the highest quality and regulatory standards.