Job Title: QA Reviewer
Company: Arbro Pharmaceuticals
Location: Bengaluru, Karnataka, India
About Arbro Pharmaceuticals:
Arbro Pharmaceuticals is a renowned name in the pharmaceutical and research sector, committed to upholding the highest standards of quality and regulatory compliance. We are dedicated to delivering excellence in our operations and are seeking talented professionals to strengthen our quality assurance team.
Job Summary:
Arbro Pharmaceuticals is conducting a walk-in interview for an experienced and meticulous QA Reviewer. This pivotal role involves the comprehensive review of analytical data, laboratory records, test reports, and all relevant quality documentation. The successful candidate will be instrumental in ensuring strict compliance with NABL (ISO/IEC 17025), USFDA, GLP, GMP, and our internal quality requirements. You will play a critical part in maintaining data integrity, supporting audit readiness, managing CAPA processes, and contributing to the continuous improvement of our robust quality systems.
Key Responsibilities:
- Quality Documentation & Review: Meticulously review analytical raw data, chromatograms, calculations, worksheets, and test reports. Ensure all laboratory records comply with SOPs, STPs, and regulatory standards. Validate Certificates of Analysis (COA) and validation reports prior to release, strictly adhering to data integrity (ALCOA+ principles).
- Regulatory Compliance: Ensure unwavering adherence to NABL accreditation requirements and ISO/IEC 17025 standards. Actively support laboratory accreditation, surveillance, and reassessment audits. Review and monitor quality system documents, SOPs, forms, specifications, and protocols.
- Method Validation & Verification: Conduct thorough reviews of method validation, method verification, method transfer, and stability study reports. Verify the accuracy, precision, linearity, and robustness of analytical methods against applicable regulatory guidelines.
- Audit Readiness & CAPA: Participate effectively in internal, external, customer, and regulatory inspections, including NABL and USFDA audits. Investigate deviations, Out-of-Specification (OOS), Out-of-Trend (OOT) incidents, and customer complaints. Prepare and review Corrective and Preventive Action (CAPA) documentation and verify effectiveness checks.
- Training & Quality Systems: Conduct essential training sessions on SOPs, quality systems, data integrity, and regulatory requirements for laboratory personnel. Ensure laboratory staff consistently comply with approved procedures and quality standards.
Required Qualifications & Skills:
- Education: B.Pharma or B.Sc in any specialization.
- Experience: 5 – 8 years of progressive experience in a Quality Assurance role within a pharmaceutical or analytical laboratory setting, preferably in a NABL/USFDA compliant environment.
- Technical Expertise: Strong foundational knowledge of NABL (ISO/IEC 17025) requirements, USFDA, GMP, GLP, and Data Integrity guidelines. Proven experience in analytical data review, documentation review, method validation, CAPA, OOS, and audit management. Proficiency in MS Office and Laboratory Information Management Systems (LIMS).
Salary: ₹4.25 – 7.5 Lacs P.A.
Walk-in Interview Details:
We invite qualified candidates to attend our walk-in interview.
- Date: August 28
- Time: 9:30 AM – 5:30 PM
- Venue: Auriga Research Pvt. Ltd, 136, 6th Cross Road, 2nd Stage, Yeshwanthpur Industrial Suburb II, Bengaluru- 560022, Karnataka, India
- Contact Person: Prathap Sagili
- Contact Number: 9392505224
