Senior Specialist – IT Audit Job

Employer
Merck
Location
West Point, PA, US
Posted
August 29 2017
Discipline
Other
Organization Type
Pharma
Senior Specialist – IT Audit-QUA006191

Description

Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.

Merck Manufacturing Division, MMD, is a team of dedicated, energetic individuals who are committed to being the most trusted supplier of pharmaceuticals and health products worldwide. Our facilities, along with our external contractors, suppliers, and partners, comprise an interdependent global manufacturing network that’s committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.

The Senior Specialist of IT Audits will conduct both internal and external (vendor) audits as determined by a risk-based selection process, compliance exposures and business drivers within Merck’s Manufacturing Division (MMD). This role will drive continuous improvement by proactively identifying, scoping and auditing manufacturing computer systems that potentially affect patient safety, product quality, and data integrity.

• Conducts computer system audits of GMP systems/operations to ensure compliance with prevailing regulatory laws and company policies through the computer system life-cycle.
• Conducts remote assessments and on-site vendor audits in support of the procurement and life-cycle monitoring of computerized system software and third party IT services.
• Responsible for the audit planning, audit execution and formal reporting of all audit results to the responsible management. Ensure responses to each audit observation is obtained and that appropriate remediation and corrective or preventive actions are taken and tracked to closure.
• Presents the results of audits to senior site and divisional management, including practical recommendations to address identified risks; requiring strong negotiation and influence skills.
• Supports the development of the GMP computerized system internal and external audit programs inclusive of procedure creation, audit tools and training delivery.
• Supports the annual development and maintenance of a risk-based audit plan/schedule including scope definition.
• Provides GMP computerized system quality and compliance consultancy and expertise to colleagues.
• Supports the analysis of quality and compliance data in order to identify and lead targeted continuous improvement efforts to improve operational process effectiveness through timely investigations and effective CAPA.
• Monitors trends, identifies compliance issues and determines opportunities for quality improvements within customer areas.
• Requests applicable resources to support audit plans.
• Is responsible for ensuring delivery of high quality and timely audit information to appropriate levels of management.
• Ensures independent and non-biased role in working with quality and compliance functional area groups to prevent any audit conflicts of interest. Collaborates with quality and compliance colleagues, as appropriate, to assure adequate focus.
• Responsible for practical knowledge of current and emerging global guidelines and regulations, relevant regulatory approaches and actions to effectively develop and advance audit strategies.
• Limited supervision required in day-to-day activities.
• Requires approximately 50% domestic and International travel for up to two weeks in duration.

Qualifications

Education Minimum Requirement:

- Bachelor's degree in Science,
Information Technology or equivalent.
- IT experience related to
Computerized Systems Development, Implementation and/or IT Operations.

Required Experience and Skills:

- Minimum of 5 years of
experience in regulated pharmaceutical manufacturing or laboratory
environment.
- Must demonstrate extensive
knowledge of the principles, theories and concepts of computerized system
validation/compliance or auditing to GMP regulations.
- Minimum of 3 years of
experience in leadership delivering validated solutions, regulated
application support or vendor oversight role.
- Familiarity and practical
experience in the implementation of quality systems in a pharmaceutical,
laboratory, or biotechnology manufacturing environment.

Preferred Experience and Skills:

- Minimum of 2 years in a
leadership capacity with proven accountability, and demonstrated excellent
interpersonal, communication, negotiation, influencing, and
problem-solving capabilities.
- GAMP or ICH (International
Council of Harmonization) Validation Guidance
- Good understanding of
Information Technology operations and maintenance.
- Understanding of Six-Sigma or
Green Belt Certification

Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life.

If you need an accommodation for the application process please email us at staffingaadar@merck.com.

Search Firm Representatives Please Read Carefully:

Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck. No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.

Visa sponsorship is not available for this position.

For more information about personal rights under Equal Employment Opportunity, visit:

EEOC Poster

EEOC GINA Supplement​

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Merck is an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.


Job: Qual Assurance & Ops Generic

Job Title:Sr. Spclst, Quality Assurance

Primary Location: NA-US-PA-West Point

Other Locations: NA-US-NJ-Whitehouse Station, NA-US-NJ-Rahway, NA-US-NJ-Kenilworth

Employee Status: Regular

Travel: Yes, 50 % of the Time

Number of Openings: 1

Company Trade Name:Merck