Senior Manager QA Documentation Job at Amneal Pharmaceuticals | Apply Now for Pharma Jobs in Hyderabad
If you are exploring Pharma Jobs in Hyderabad, this latest opportunity with Amneal Careers offers a leadership role in Quality Assurance Documentation. This Senior Manager position in Amneal Careers is ideal for experienced QA professionals looking to grow within oncology manufacturing while ensuring regulatory compliance, validation governance, and cGMP excellence in Hyderabad.
- Position: Senior Manager, QA Documentation
- Location: Hyderabad, Telangana, India.
- Job Identification: 7261
About the Company
Amneal Pharmaceuticals is a global pharmaceutical company focused on developing, manufacturing, and distributing high-quality generic and specialty medicines. Through Amneal Careers, professionals get the opportunity to work in advanced oncology manufacturing facilities that operate with strong regulatory compliance and a robust Quality Management System.
Job Description
- Responsible for overall QA function compliance with various regulatory guidelines and standard operating procedures in practice at the site.
- Review and monitor quality systems and provide guidance to the team for implementation.
- Responsible for Review and approval of Batch Manufacturing Record (BMR) & Batch Packing Records (BPRs).
- Responsible for the preparation, review, and Approval of the Media Fill Protocol Report.
- Responsible for athe ssurance of cleaning, sterilization, and aseptic manipulations of components.
- Responsible for implementing, monitoring, and processing finished products at every stage as per defined norms, as per the master BMR and BPR, implement system for testing and release or rejection of finished products with proper approvals.
- Responsible for sampling verification and coordination during validation studies (process/cleaning validation).
- Responsible for commercial batch release to market.
- Responsible for Quality Assurance activities in the process.
- Responsible for the preparation, review, and implementation of SOPs.
- Identify potential problems and coordinate the resolution of issues.
- To develop and implement systems for handling product complaints and evaluate these complaints to avoid recurrence and maintain necessary records.
- Responsible for the assessment and approval of Change Control, Deviation, CAPA, Investigation, etc.
- Implement a system for product Recall and take action on product recalls, investigate reasons, and report when required.
- Ensure environmental (Active, Passive, Surface & Personal) monitoring trends.
- Ensure batch documents are reviewed as cGMP records.
- Lead and facilitate audit and compliance at the site. Enhance and reinforce quality culture to ensure the site is in a continued state of compliance and readiness.
- Participation in management review of process performance, product quality, quality management system, and advocating for continual improvement.
- Involved in any failure investigations and support the investigation team as and when required.
- Responsible for the preparation, review, and approval of risk assessment activities related to Equipment/Process/Facility/System.
Additional Responsibilities
- Overall accountable for strategy, oversight, and governance of all Validation activities across the shop floor, ensuring compliance with regulatory and internal quality standards.
- Lead the review and approval of Qualification & Requalification protocols, reports, and engineering drawings for Amneal Oncology facilities.
- Review, authorize, and ensure timely submission of data for new products, variations, and modifications related to all oncology plant products manufactured at Hyderabad.
- Ensure completeness and accuracy of BMR, BPR, and FP manufacturing/testing documents before communication to Regulatory Affairs, ensuring compliance with cGMP and RA requirements.
- Oversee and approve Artwork for commercialization, ensuring regulatory alignment and error-free execution.
- Ensure secure management, retention, and traceability of all artwork-related documentation and records.
- Perform any additional tasks assigned by the Head of Department in alignment with business and regulatory priorities.
Qualifications
- B. Pharmacy / M. Pharmacy
