- ISO 13485
- Quality Assurance
- Computer Skills
Allergan plc (NYSE: AGN) is a bold, global pharmaceutical company and a leader in a new industry model - Growth Pharma. Allergan is focused on developing, manufacturing and commercializing branded pharmaceutical, device, biologic, surgical and regenerative medicine products for patients around the world.
Allergan markets a portfolio of leading brands and best-in-class products for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women's health, urology and anti-infective therapeutic categories. With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives every day.
Allergan is a company that will inspire you to aim high with your ambition. Where you can build bridges all over the world. Where you can power ideas that drive change. And where you will act fast and drive results for customers and patients. Power your future & join our bold team.
This position is responsible for the development and maintenance of quality improvement processes related to the compliance aspects of our business and in accordance with the FDA Code of Federal Regulations, European Regulations, and other Ministry of Health regulatory requirements. Responsible for managing the Internal Audit program at the site.
Main Areas of Responsibilities
This position will be responsible for: notification of new or changing regulations (FDA, European, and worldwide) and cGMP trends relevant to our facility and dissemination of this information on a plant wide basis, development and maintaining the internal audit program and auditors, tracking and facilitation of remedial action for external and internal audits and quality metrics tracking.
This job is responsible for:
Developing the internal audit schedule for the site and performing and supporting all internal audits from start to finish (this includes but is not limited to scheduling the audit, picking audit team, opening and closing meeting, performing audit, entering all observations into Global Trackwise and following them through to completion)
Supporting FDA, Ministry of Health and other Regulatory Inspections and customer audits of the site.
Performing Mock-FDA inspections as needed and preparing the site for external Regulatory inspections and customer audits.
Communicate to management changes to regulations and work with the site to implement required changes to ensure compliance and operational excellence.
Interpret regulations and standards and serve as an advisor to Waco Staff on FDA/EU/ROW GMP regulations and guidance.
Proactively seek to affect change using methods that will prevent or reduce the number of observations identified during audits/inspections.
Supporting the design and management of the vendor audit and certification program with Supplier Quality.
Performing GAP analysis of new or changing regulations.
Participate in product investigations related to Field Alerts and other investigations as required.
Review SOPs, regulatory filings, and commitments for compliance with regulations as needed.
Maintain quality metrics, develops trend data of audit/inspection observations and CAPAs and communicate results expediently to applicable groups.
Provide support for external vendor audits and Global compliance projects
Performs other duties as assigned
Incumbent has full authority to make decisions and/or take action that is required to carry out job duties. Allergan internal requirements include compliance with ethics, environmental health and safety, financial, human resources, cGMP procedures, general business policies, requirements and objectives. The incumbent must be willing to take temporary assignments as required.
Allergan is a regulated company and the incumbent is expected to be fully compliant with all criteria established by governmental agencies, Ministry of Health, and legislative requirements including, but not limited to: the FDA, European Community (EC), ISO 13485 - Medical Devices, European Economic Community Medical Device Directive (MDD), Canadian Medical Device Regulations (CMDR), OSHA, Sarbanes-Oxley, EPA, DOT, EEOC, and ADA.
Incumbent will work to ensure that the company is in compliance with all environmental, health and safety requirements and assure our business practices enhance the welfare of our customers, employees and the community in which we operate.
The following listed requirements need to be met at a minimum level to be considered for the job:
A minimum of six (6) years of experience in Operations and/or Quality Assurance/Control
Strong computer skills (Excel, PowerPoint, SAP, Word, etc.)
Knowledge of drug regulations, quality systems, and auditing.
Sterile products experience.
The below skills are attributes that may not be mandatory but are definitely desired in the ideal candidate.
Basic Quality System knowledge (FDA/GMP, ISO 13485/13488).
Knowledge of cGMP’s and global regulations.
Strong general Quality System knowledge and aseptic processing knowledge.
Able to understand, interpret and present information to show how Allergan’s processes and records meets regulatory requirements.
Ability to organize, develop, and prepare written investigations and responses to Regulatory agencies and customer audits
Ability to interface and interact with all levels of personnel within and outside of the organization and globally.
Strong interpersonal and presentation skills with the ability to communicate clearly and professional, written and verbally.
Must be able to critically think through opportunities and use a variety of problem solving methods.
Proven ability to plan, execute, document, and follow up on internal and external audits.
Ability to effect change without direct responsibility for all levels of the organization.
Ability to thrive in a team environment.
Knowledge of problem solving methods such as KTA’s, HACCP, or equivalent.
A Bachelor’s Degree in Science, Engineering or a related field from an accredited institution.