Hiring: Quality Control – Microbiology Professionals AUROBINDO PHARMA LTD. We are looking for skilled QC professionals to join our Quality team at our Naidupeta unit.
Job Details:
🔹 Position: 𝐀𝐌/𝐃𝐌 – 𝐌𝐢𝐜𝐫𝐨𝐛𝐢𝐨𝐥𝐨𝐠𝐲
🔹 Experience: 9 – 15 Years.
📍 Location: Naidupeta, Tirupati
𝐊𝐞𝐲 𝐑𝐞𝐪𝐮𝐢𝐫𝐞𝐦𝐞𝐧𝐭𝐬:
- Operational Leadership: Manage day-to-day operations of the microbiology lab, ensuring all tests (Sterility, Bacterial Endotoxin Test (BET), and Microbial Limit Tests (MLT)) are performed according to SOPs.
- Environmental Monitoring: Oversee and review environmental monitoring (EM) of cleanrooms and production areas to ensure sterile formulation environments are maintained.
- Method Validation: Lead the development and validation of microbiological test methods for new formulation products, including Gowning and Disinfectant validation.
- Compliance & Audits: Ensure the lab is “audit-ready” at all times. Participate in internal and external regulatory audits (e.g., NABL, WHO-GMP).
Investigations: Lead root-cause investigations for out-of-specification (OOS) results, deviations, and contamination incidents; implement corrective and preventive actions (CAPA).
Quality Management: Review and approve laboratory data, trending reports, and technical protocols. Manage the calibration and maintenance schedule for all lab equipment (LAF, Autoclaves, Incubators).
Required Qualifications
- Education: Master’s degree (M. Sc) or Bachelor’s in Microbiology or Biotechnology. M. Pharm is also highly valued for formulation-specific roles.
- Experience: 6–10 years of progressive experience in a pharmaceutical microbiology laboratory, with at least 2–3 years in a supervisory or assistant management role.
Technical Skills:
- Deep knowledge of GLP/GMP and pharmacopoeia standards (USP/BP/EP/IP).
- Hands-on experience with water system validation and sterile manufacturing processes.
- Proficiency in software like LIMS for data management.
📩 𝐀𝐩𝐩𝐥𝐲 𝐍𝐨𝐰:
- Interested candidates, please share your updated CV to:
PraveenKumar.Gullipalli@aurobindo.com - Please repost ♻️ to help connections find this opportunity!
Hiring: 𝐐𝐔𝐀𝐋𝐈𝐓𝐘 𝐀𝐒𝐒𝐔𝐑𝐀𝐍𝐂𝐄 @ AUROBINDO PHARMA LTD for Assistant Manager in the Quality Management System (QMS) /Market complaints section, 𝐅𝐨𝐫𝐦𝐮𝐥𝐚𝐭𝐢𝐨𝐧, APL Healthcare Ltd Unit IV, 𝐍𝐚𝐢𝐝𝐮𝐩𝐞𝐭𝐚, 𝐓𝐢𝐫𝐮𝐩𝐚𝐭𝐢.
Job Title: Sr. Executive Assistant Manager – Quality Assurance (QMS)/MC
Job Summary:
We are looking for a highly skilled QA professional to lead the implementation, monitoring, and continuous improvement of our site Quality Management System (QMS). The successful candidate will ensure all formulation manufacturing activities comply with current Good Manufacturing Practices (cGMP) and international regulatory standards (USFDA, MHRA, WHO-GMP).
Key Responsibilities
- QMS Element Administration: Lead the management and timely closure of critical QMS elements, including Deviations, Change Controls, and CAPA (Corrective and Preventive Actions).
- Investigation Leadership: Lead and approve root-cause investigations for Out of Specification (OOS), Out of Trend (OOT) results, and market complaints.
- Risk Management: Conduct and review Quality Risk Assessments (QRA) to identify and mitigate potential quality risks in the formulation process.
- Audit Preparedness: Act as a key member in preparing the site for external regulatory, third-party, and internal audits; manage post-audit CAPA implementation.
- Documentation Control: Oversee the issuance, revision, and archival of controlled documents such as SOPs, Master Formula Records (MFR), and Batch Manufacturing Records (BMR).
- Compliance Monitoring: Conduct routine GMP walkthroughs in manufacturing departments to ensure shop-floor adherence to protocols and data integrity policies.
Required Qualifications:
- Education: B.Pharm, M.Pharm, or M.Sc in Chemistry/Biotechnology.
- Experience: 7–12 years of experience in QA/QMS within a pharmaceutical formulation facility, with significant experience in a supervisory role.
- Regulatory Knowledge: Deep understanding of cGMP, USFDA, MHRA, and ICH guidelines.
- Technical Skills: Proficiency in QMS software (e.g., TrackWise) and Laboratory Information Management Systems (LIMS) is highly desirable.
📩 𝐀𝐩𝐩𝐥𝐲 𝐍𝐨𝐰:
- Interested candidates, please share your updated CV to:
ganesh.janne@aurobindo.com - Please repost ♻️ to help connections find this opportunity!
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