Aurobindo Pharma Limited, through its subsidiary APL Healthcare Limited, is expanding its team at Unit 4 in Naidupeta, Tirupati. The company is actively recruiting for a key role in the Quality Assurance department, focusing on Quality Management System (QMS) and Market Complaints in the formulations division. This opportunity is ideal for experienced professionals seeking to contribute to a leading pharmaceutical organization committed to global regulatory compliance and high-quality standards.
With a strong emphasis on cGMP and international guidelines like USFDA, MHRA, and WHO-GMP, this position offers a chance to lead critical quality processes in a dynamic formulation manufacturing environment.
Job Overview
The role of Sr. Executive/Assistant Manager – Quality Assurance (QMS/Market Complaints) involves overseeing the site’s Quality Management System, ensuring compliance, and driving continuous improvement. The position is based at APL Healthcare Limited, Unit 4, Naidupeta, and involves virtual interviews for shortlisted candidates.
Key Responsibilities
As a leader in the QA team, you will be responsible for:
- Leading the management and timely closure of critical QMS elements, including Deviations, Change Controls, and Corrective and Preventive Actions (CAPA).
- Conducting and approving root-cause investigations for Out of Specification (OOS), Out of Trend (OOT) results, and market complaints.
- Performing and reviewing Quality Risk Assessments (QRA) to identify and mitigate risks in formulation processes.
- Preparing the site for external regulatory audits (USFDA, MHRA, etc.), third-party audits, and internal audits, while managing post-audit CAPA implementation.
- Overseeing documentation control, including issuance, revision, and archival of SOPs, Master Formula Records (MFR), and Batch Manufacturing Records (BMR).
- Conducting routine GMP walkthroughs in manufacturing departments to ensure adherence to protocols and data integrity.
Required Qualifications and Skills
To excel in this role, candidates should meet the following criteria:
- Education: B.Pharm, M.Pharm, or M.Sc in Chemistry/Biotechnology.
- Experience: 4-12 years in Quality Assurance/QMS within a pharmaceutical formulation facility, with significant supervisory experience.
- Regulatory Knowledge: In-depth understanding of cGMP, USFDA, MHRA, ICH, and WHO-GMP guidelines.
- Technical Skills: Proficiency in QMS software (e.g., TrackWise) and Laboratory Information Management Systems (LIMS) is highly desirable.
- Strong investigation, risk management, and audit preparedness skills.
Salary and Benefits
The compensation for this role is competitive and commensurate with experience. Based on industry standards and similar positions at Aurobindo Pharma, the expected salary range is INR 9-14 Lakhs per annum. Benefits include standard pharmaceutical industry perks such as health insurance, provident fund, gratuity, and opportunities for professional growth in a globally recognized organization.
How to Apply
Interested candidates are invited to share their updated CV via email. The interview process will be conducted virtually.
- Email your CV to:ganesh.janne@aurobindo.com
- For queries, contact: Mobile No. 7036942226 (as mentioned in alternate postings)
Don’t miss this opportunity to advance your career with Aurobindo Pharma. Apply today and be part of a team dedicated to excellence in pharmaceutical manufacturing!
