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Quality Management System (QMS)
We're Hiring: Quality Management System (QMS)
We are seeking a detail-oriented and experienced QMS professional to join our oncology manufacturing division. The ideal candidate will be responsible for maintaining, monitoring, and continuously improving the Quality Management System, ensuring compliance with regulatory requirements (USFDA, EU-GMP, WHO-GMP, etc.) with a strong focus on OOS, OOT, CAPA, and Change Control management.
- Location: Shameerpet
- Department: Quality Assurance
- Qualification: B.Pharm / M.Pharm / M.Sc
- Experience: 3 to 8 Years (preferably in oncology manufacturing)
Key Responsibilities:
🔹 Out of Specification (OOS) & Out of Trend (OOT) Management
Investigate and document OOS and OOT results in compliance with SOPs and regulatory guidelines.
Coordinate with cross-functional teams (QC, QA, Production) for root cause analysis.
Ensure timely reporting and closure of all investigations.
Review trending data and escalate any quality signal appropriately.
🔹 CAPA Implementation
Lead and support CAPA initiation, execution, and effectiveness checks.
Identify root causes using tools such as Fishbone, 5 Whys, etc.
Ensure timely completion and documentation of CAPA activities.
🔹 Change Control Management
Evaluate, assess, and manage changes in processes, equipment, documents, or systems that may impact product quality.
Coordinate risk assessment and impact analysis.
Ensure approvals and documentation are in line with regulatory standards.
🔹 QMS Documentation & Compliance
Maintain controlled documents: SOPs, quality manuals, forms, etc.
Participate in internal audits and regulatory inspections.
Support continuous improvement initiatives in quality systems.
🔹 Training & Awareness
Conduct periodic training on QMS elements to ensure team compliance.
Promote a culture of quality across departments.
Key Skills & Qualifications:
✅ Bachelor’s / Master’s degree in Pharmacy, Chemistry, or related field.
✅ 3–8 years of experience in QMS within a pharmaceutical / oncology manufacturing setup.
✅ Sound knowledge of cGMP, ICH guidelines, and regulatory requirements.
✅ Proficient in handling QMS software/document management systems.
✅ Excellent communication and analytical skills.