Senior Manager, QA Documentation

Amneal Pharmaceuticals LLC; Hyderabad; On-site; INR 1,800,000 - 2,600,000; Full time

Job summary

Amneal Pharmaceuticals LLC seeks a senior QA professional to oversee site QA compliance. The role ensures adherence to regulatory guidelines and SOPs, with responsibility for approving BMR/BPR and media fill protocols.

The incumbent will supervise cleaning, sterilization and aseptic handling, coordinate product release, and drive quality systems through audits and continuous improvement. The position requires strong experience in QA, cGMP practices, and regulatory affairs, and reports to the

Qualifications

• B. Pharmacy or M. Pharmacy degree required.
• Experience with QA systems and regulatory guidelines is preferred.

Responsibilities

• Ensure QA function complies with regulatory guidelines and SOPs at the site.
• Review and approve Batch Manufacturing Records (BMR) and Batch Packing Records (BPR).
• Prepare, review and approve Media Fill Protocols and reports.
• Assure cleaning, sterilization and aseptic handling of components.
• Oversee testing, release or rejection of finished products per master BMR/BPR.
• Lead audit and compliance activities and drive continual improvement.

Education

B. Pharmacy

M. Pharmacy

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 team for implementation.
• Responsible for Review and approval of Batch Manufacturing Record (BMR) & Batch Packing Records (BPRs).
• Responsible for preparation, review and Approval of Media Fill Protocol, Report.
• Responsible for assurance of cleaning, sterilization and aseptic manipulations of components.
• Responsible to implement, monitor and Processing of finished products at every stage as per defined norms, as per the master BMR and BPR, implement system for testing and release or reject of finished products by 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 process.
• Responsible for preparation, Review and implementation of SOP's
• Identify potential problems and co-ordinate resolution to issues.
• To develop and implement systems for handling product complaints and evaluate these complaints to avoid the re-occurrence in and maintenance of necessary records thereof.
• Responsible for the assessment and approval of Change Control, Deviation, CAPA, Investigation etc.
• To implement a system for product Recall and to take action on product recalls, investigate the reasons and report, whenever required.
• To ensure environmental (Active, Passive, Surface & Personal) monitoring trends.
• To ensure batch documents are reviewed as for cGMP records.
• Lead and facilitate for audit and compliance at site. Enhance and reinforce quality culture to ensure site in at continued state of compliance and readiness.
• Participation in management review of process performance, product quality and quality management system and advocating continual improvement.
• To involve in any failure investigations and support to investigation team as and when required.
• Responsible for Preparation, review and approval of risk assessment activity related to Equipment /Process / Facility / 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 team for implementation.
• Responsible for Review and approval of Batch Manufacturing Record (BMR) & Batch Packing Records (BPRs).
• Responsible for preparation, review and Approval of Media Fill Protocol, Report.
• Responsible for assurance of cleaning, sterilization and aseptic manipulations of components.
• Responsible to implement, monitor and Processing of finished products at every stage as per defined norms, as per the master BMR and BPR, implement system for testing and release or reject of finished products by 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 process.
• Responsible for preparation, Review and implementation of SOP's
• Identify potential problems and co-ordinate resolution to issues.
• To develop and implement systems for handling product complaints and evaluate these complaints to avoid the re-occurrence in and maintenance of necessary records thereof.
• Responsible for the assessment and approval of Change Control, Deviation, CAPA, Investigation etc.
• To implement a system for product Recall and to take action on product recalls, investigate the reasons and report, whenever required.
• To ensure environmental (Active, Passive, Surface & Personal) monitoring trends.
• To ensure batch documents are reviewed as for cGMP records.
• Lead and facilitate for audit and compliance at site. Enhance and reinforce quality culture to ensure site in at continued state of compliance and readiness.
• Participation in management review of process performance, product quality and quality management system and advocating continual improvement.
• To involve in any failure investigations and support to investigation team as and when required.
• Responsible for Preparation, review and approval of risk assessment activity related to Equipment /Process / Facility / System.

Additional Or Updated 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 pertaining to 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

Qualification - B. Pharmacy / M. Pharmacy