The Compliance/Regulatory Specialist ensures compliance with regulations governing the manufacturing, testing, warehousing, and distribution of pharmaceutical drug products at Piramal Pharma Solutions, Inc. - Lexington. This position will support overall cGMP compliance and the quality systems and regulatory compliance throughout the site. This position will report directly to the Associate Director, Compliance and Regulatory.
Provide support and coordination for compliance and regulatory-related projects.
Apply cGMP (Current Good Manufacturing Practice) concepts into validation and change control, supplier quality management, quality system documentation review, and Development and/or modification of quality systems and other cGMP processes.
Create, prepare and review technical reports.
Conduct internal and external/supplier audits.
Perform activities supporting the supplier quality management program, including supplier evaluations, audits, vendor requests/inquiries, and supplier complaint follow-up.
Interact with clients regarding compliance/regulatory issues.
Maintain current knowledge base of existing and emerging regulations by developing cGMP/Compliance and/or Regulatory policies and training for staff.
Conduct and/or annual product review activities.
Coordinate, prepare and review regulatory filing submissions.
Expected to cross-train in identified quality unit activities outside of the Compliance and Regulatory department in a supporting capacity.
Bachelor's degree in a scientific discipline or equivalent with 4 years of QA and/or Regulatory experience in a cGMP/FDA regulated environment (sterile manufacturing (injectables) preferred).
Working knowledge of cGMP (Current Good Manufacturing Practice) regulations, guidance, and general compliance expectations.
Working knowledge of investigational techniques, including but not limited to root cause analysis, risk assessment, impact evaluation, and technical report writing.
Experience with Supplier Quality Management programs and/or auditing is preferred.
Knowledge of Common Technical Document (primarily Chemistry and Manufacturing Controls (CMC)) format, content, and filing requirements for US and EU. Other jurisdictions a plus.
Technical writing experience is required.
Must be a detail oriented team player with effective planning, analytical thinking, organization, and execution skills.
Must have proficiency in the Microsoft Office Suite.
Excellent communication skills with internal and external personnel is essential.
Ability to work effectively at a fast pace with cross-functional departments and manage priorities to meet timelines.
Must be Innovative, proactive, resourceful and committed to continuous improvement.
Working knowledge of cGMP data management systems (EDMS, Trackwise, and/or SAP) is preferred.
The position requires the ability to work in a high demand office and manufacturing setting with possible time spent performing "on the floor" activities in lab, manufacturing, and warehouse settings. Position may require extended hours including evenings and weekends. The employee may be exposed to materials of potential high potency and/or toxicity in a limited capacity.
Piramal Enterprises Ltd.