Specialist, QA, GMP, Data Integrity

At West, we’re a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West’s indelible mark on the healthcare industry has just begun. A name started our story. How will yours help write our future?  

 

There’s no better place to join an inclusive community of professionals with opportunities for lifelong learning, growth and development. Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families.  

 

We believe in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier environment and planet through our sustainability efforts.  

Job Summary:

In this role you will be responsible for implementing local activities in West global data integrity programs and drive local initiatives in conjunction with the data integrity program manager and local site QA and laboratory  and QC managers. This role will include the project management of the local DI projects and the co-ordination with the site's QC and laboratory to ensure execution of the project plan.

 

Essential Duties and Responsibilities:

• Drives implementation of activities defined in West global Data Integrity Programs.
• Supports all relevant functions as local SME on DI.
• Leads local DI projects, reporting of regular status updates, stakeholder communication.
• Leads assigned global subprojects with agreement with local QA manager and DI core team
• Be an active part of global Data Integrity team and share best practices with global GMP specialists
• Supports all affected functions in bringing their systems and processes into compliance with GMP and DI principles and in maintaining that state.
• Participates in creation of Enterprise and local procedures on relevant DI topics and support all affected functions in their implementation, such us:
  • Data integrity audits
  • Excel Validation
  • Audit trail
  • Lab/ QC systems administration
• Provides functional expertise and advice for verification of Excel Spreadsheets, supports set-up of computerized systems, instrument qualification, computer system validation etc. for the site.
• Drives Excel spreadsheet validation for laboratories and QA and Quality control.
• Drives completion of Audit trail gap assessments and implementation of Audit trail reviews.
• Supports communication and responses for typical customer questions on DI, e.g. during audits, and educates relevant functions accordingly.
• Leads Internal monthly Spot Check Data Audits, quarterly Auditing of Historical data and annual site reports.
• Supports Laboratory and QC in the set-up and Administration of computerized systems, managing of access control and time and date control to electronical systems.
• Supports initiatives to assure compliance of electronic data storage, backup and archiving.

 

Basic Qualifications: 

Required:

• 3rd Level Qualification in a Business, Quality, Engineering or Scientific discipline

 

Preferred Knowledge, Skills and Abilities:

• 5 years’ previous experience in a ISO 9001, ISO13485 or cGMP environment.

• Experience in use of electronic documentation management system.
• Experience in the use of training management systems.
• Must have superior computer skills including, but not limited to MS Office applications such as word, excel, PowerPoint
• Must also have effective problem solving and interpersonal skills
• Excellent communication and interpersonal skills
• Must have exceptional organizational and communication (both oral and written) skills
• Good problem solving, conflict resolution and negotiation skills required and must be able to interface with employees in all levels of the organization.
• Document control and record keeping skills in a GMP or ISO also required

 

Desired

• Master Control, and SAP QM 
• General understanding of manufacturing and plant operations
• Audit management experience

 

Competencies

• Quality planning and communication skills.
• Strong technical writing ability.
• Ability to liaise with customers and suppliers in an informed professional manner.
• Excellent IT, communication and interpersonal skills using current office technologies.