Are you a seasoned professional in the Life Sciences industry looking to elevate your career? tCognition, a trusted leader in technology and consulting services for pharmaceutical and biotech sectors, is hiring an Analytical Quality Assurance (AQA) Specialist for our Quality Assurance team in Bengaluru, India. This role offers an exciting opportunity to ensure compliance with global standards and drive quality in analytical operations. Apply now and take the next step in your career with a company committed to innovation and excellence.
Application Details
- Location: Bengaluru, Karnataka, India
- Application Method: Send your resume to resume@tCognition.com with the subject line “AQA Specialist Application – Bengaluru”
- Application Deadline: May 15th, 2025
- Website: www.tCognition.com
Note: Candidates must submit an updated resume, academic certificates, and relevant experience letters. Immediate joiners are preferred.
Why Join tCognition?
tCognition empowers global Life Sciences organizations with cutting-edge solutions in quality assurance, regulatory compliance, and digital transformation. Our Bengaluru office, located in the heart of India’s biotech hub, fosters a collaborative environment where professionals thrive on challenging projects.
With a focus on cGMP compliance and a commitment to employee growth, tCognition is the ideal place to advance your career in pharmaceutical quality assurance.
Job Position: Analytical Quality Assurance (AQA) Specialist
We are seeking an experienced AQA Specialist to oversee quality assurance for analytical operations, ensuring adherence to regulatory guidelines and internal standards in a GMP-compliant environment.
Job Details
- Experience: 8–12 years in QA/QC within GMP-compliant pharma/biotech environments
- Qualification: Master’s degree in Life Sciences, Chemistry, or related field (PhD preferred)
- Location: Bengaluru, India
Key Responsibilities
- Provide QA oversight to Quality Control (QC) laboratories for raw material, in-process, and final product testing
- Review and approve analytical data, batch records, audit trails, and documentation
- Develop and update SOPs, APQRs (Annual Product Quality Reviews), and validation protocols (IQ/OQ/PQ)
- Lead investigations for OOS (Out of Specification), OOT (Out of Trend), and OOL (Out of Limit) incidents, managing CAPAs
- Coordinate internal and external audits, change controls, and vendor qualifications
- Support method validation, equipment qualification, and Computer System Validation (CSV) per 21 CFR Part 11
- Track and enhance QMS performance indicators to optimize operational efficiency
Required Skills and Qualifications
| Category | Details |
|---|---|
| Education | Master’s degree in Life Sciences, Chemistry, or related field (PhD preferred) |
| Experience | 8–12 years in QA/QC within GMP-compliant pharma/biotech environments |
| Technical Skills | Proficiency in HPLC, spectroscopy (UV, IR), GC, and analytical instrumentation |
| Regulatory Knowledge | Strong understanding of cGMP, GxP, FDA, and ICH guidelines |
| Soft Skills | Excellent documentation, analytical, and communication skills |
| Preferred Tools | Familiarity with QMS tools like TrackWise or MasterControl |
Why This Role?
- Impactful Work: Contribute to ensuring the quality and safety of pharmaceutical products.
- Career Growth: Work on high-visibility projects with opportunities for skill development.
- Collaborative Environment: Engage with cross-functional teams in a dynamic, tech-driven setting.
How to Apply
To apply for the AQA Specialist position, follow these steps:
- Prepare Your Documents: Update your resume, highlighting your 8–12 years of QA/QC experience, and gather academic certificates and experience letters.
- Email Your Application: Send your documents to resume@tCognition.com with the subject line “AQA Specialist Application – Bengaluru.”
- Include Key Details: Mention your total experience, current CTC, expected CTC, and notice period in your email.
- Research tCognition: Visit www.tCognition.com to learn about our Life Sciences solutions and quality assurance expertise.
- Prepare for the Interview: Be ready to discuss your experience with HPLC, OOS investigations, 21 CFR Part 11 compliance, or QMS metrics.
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Why Bengaluru?
Bengaluru, known as India’s biotech and IT capital, offers a vibrant ecosystem for Life Sciences professionals. tCognition’s office in Brookefield, Kundalahalli, is located in a bustling tech park, providing access to modern infrastructure and a collaborative work culture. Learn more about Bengaluru’s biotech industry.
Contact Information
For inquiries or to apply, reach out to:
- Email: resume@tCognition.com
- Office Address: Brigade Tech Gardens, Brookefield, Kundalahalli, Bengaluru, Karnataka 560037
- Website: www.tCognition.com
Don’t miss this chance to join a leader in Life Sciences quality assurance. Apply by May 15th, 2025, and shape the future of pharmaceutical excellence with tCognition!
