The position is responsible for assisting in maintaining and implementation of Quality and Compliance standards and systems. This position carries out quality functions as needed under the direction of the Quality Assurance management staff. The candidate assists in managing 3rd Party CMO Quality affairs to include CMO audits, Quality Agreements, Change Controls, Deviations, CAPA and releases for timely delivery of products. The position maintains quality metrics for periodic site reviews and will assist in FDA inspections as needed.
- This position has no direct reports.
- Prepare Annual Product Quality Review (APQR) reports for all the products including communication with the contract giver and Global Regulatory Affairs as needed.
- Prepare Annual Product Quality Review that includes:
- Gather and Review Manufacturing Batch Records.
- Review of all the Raw and Packaging Material used for Manufacturing.
- Review Change Control Forms, Environmental Records, Stability Data, and the Deviations Report.
- Review Qualification and Validation status of Processes and Equipment, Complaints-Rework- Returned/Salvaged lots and Recalls and Field Alerts and Quality Agreements etc.
- Perform and assist in Quality and Compliance activities including but not limited to:
- Market Complaint handling and investigations.
- Adverse Drug Event handling and reporting.
- Field Alert Reporting to the agency.
- Investigations regarding Manufacturing Deviations, Non-conformances, OOS and Lab Deviations.
- Internal audits, Contract Giver Audits and Regulatory Agency Audits.
- Communication with Global Regulatory Affairs and Contract Giver as needed for the listed tasks.
- Assist in managing the established cGMP Training Program.
- Assist in batch manufacturing & packaging records review process and batch release process as needed, such as batches manufactured for ANDA submissions and commercial distribution.
- Review, revise and create standard operating procedures (SOPs) as a part of periodic review and ongoing improvement efforts.
- Prepare annual trend reports including but not limited to OOS, Lab Deviations, Purified Water Analysis, Microbial Air Quality Monitoring, Temperature, Humidity Monitoring and Change Control
- Back-up for the document and retain sample room control coordinator.
- Support the handling and control DEA related activity as required.
- All other QA department job related duties performed
Specialized Skills and Knowledge:
- Bachelor's in science discipline in Life Sciences, pharmaceutical science etc.
- Minimum of 5 years of experience in different Quality Assurance, Quality Compliance or Quality Systems functions involving pharmaceutical products manufacturing, packaging, testing, and distribution
- Must be able to work individually on assigned projects with very minimal guidance and work cross-functionally or team set-up locally and globally with all Emcure sites for above listed job functions.
- Must have excellent written and verbal English skills.
- Preferred experience of working in the CMO space, handling CMOs, auditing pharmaceutical components / products manufacturing facilities for cGMP compliance.
- Knowledge, experience and understanding of Quality systems within a solid dose manufacturing environment.
- Preferred working knowledge of Quality functions in pharmaceutical electronic systems such as eLMS, Trackwise, LIMS, eBMR/BPR. Etc.
- Advanced level computer skills in Microsoft Word, PowerPoint and Excel.
- Have basic statistical skills to understand and interpret Quality Assurance data scientifically.
1. Analytical skills.
2. Problem identification and solving skills
3. Communication and presentation skills.