Quality Engineer III - Internal Audits
Posted on: October 9, 2019
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.?Position Overview?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
- 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
- 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
- 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
- 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
- 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.
Requirements?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
- Strong computer skills (Excel, PowerPoint, SAP, Word,
- Knowledge of drug regulations, quality systems, and
- Sterile products experience.Preferred Skills/Qualifications?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
- Able to understand, interpret and present information to show
how Allergan?s processes and records meets regulatory
- Ability to organize, develop, and prepare written
investigations and responses to Regulatory agencies and customer
- 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
- A Bachelor?s Degree in Science, Engineering or a related field
from an accredited institution.? #LI-SA2?
Keywords: Allergan, Waco , Quality Engineer III - Internal Audits, Engineering , Waco, Texas
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