Senior Quality Engineer

Who we are

Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with.

The opportunity

This position is responsible for providing Quality Assurance support to Manufacturing, Supply Chain and Quality Control Laboratories by providing QA review and approval of new and existing methods/procedures, validation/transfer protocols, investigation documentation, and process/facility change control documents.  This position leads cross-functional teams to track and trend investigational data, and create value through process improvements and failure reduction activities. The Senior Quality Engineer provides representation for quality management. 

How you’ll spend your day

All areas of responsibility listed below are essential to the satisfactory performance of this position by any incumbents with reasonable accommodation if necessary. Any non-essential functions are assumed to be included in other related duties or assignments.  

• Responsible for providing a thorough and timely review/approval or author/execution of cGMP documents and processes such as those related to deviations, investigations, equipment and facilities maintenance and calibration, protocols and reports, and facility controls, instruments, and procedures. 
• Responsible for working with operating departments to facilitate process improvements and lean concepts.  
• Responsible for leading cross functional improvement and process monitoring teams to mitigate unfavorable trends. 
• Responsible for providing first response and ongoing QA presence for quality and compliance issues on the manufacturing floor and as needed in the laboratories. 
• Responsible for evaluating reports of deviation from defined processes and working with QA to determine if incidents should be escalated to an event investigation. 
• Responsible for conducting comprehensive investigations of critical, complex and/or challenging events as assigned. 
• Responsible for serving as QA lead on research and development products and related document reviews/approvals – including change control items, protocols, batch records and deviations as applicable and product disposition. 
• Responsible for working with the laboratory to investigate OOT and OOS events, providing feedback and manufacturing information. 
• Responsible for compiling and maintaining metrics and tracking logs for site’s quality KPI’s or other functions. 
• Responsible for supporting internal/external, scheduled and unscheduled audits of operational areas. 
• Responsible for supporting activities within electronic systems as needed, such as LIMS, TrackWise, EAM. 
• Responsible for serving as QA backup for final review/release of production batch records, managing the site change control system and for validation/qualification protocols and related activities. 
• Responsible for completing training requirements and maintaining compliance with all assignments.    
• Responsible for maintaining work areas and performing job functions in a safe and efficient manner in accordance with company policies and procedures, Good Manufacturing Practices (cGMP’s), Standard Operating Procedures (SOP’s) and Batch Record instructions.  
• Responsible for performing additional related duties as assigned. 

Your experience and qualifications

Any equivalent combination of education, training and/or experience that fulfills the requirements of the position will be considered.  

Education/Certification/Experience: 

• Requires a Bachelor’s Degree or equivalent with a minimum of seven years relevant progressive QA experience in the pharmaceutical or a related industry. 
• Prefer degree in Science or Engineering. 
• Preferred experience in a solid dose manufacturing environment. 
• Requires experience with and an in-depth knowledge of cGMP and other applicable industry regulatory requirements as they relate to the production of pharmaceutical products and associated quality systems. 
• Requires experience with the handling of deviations, investigations and CAPA’s. 
• Requires experience with managing partner relationships. 
• Experience with Manufacturing/Quality syst