Validation Officer

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Almac Group is hiring a Validation Specialist for our Souderton, PA location. The Validation Specialist - Computerized Systems will work as part of the Quality department, you will be responsible for coordinating validation activities, at any Almac Clinical Services site, to ensure that simple computerized systems achieve compliance with business and regulatory requirements and to ensure their validated status is maintained throughout their operational lifetime.
 
Responsibilities include but are not limited to:
  • Ensure that quality, regulatory and GMP compliance are implemented and maintained during the validation of computerized system projects.
  • Ensure each new computerized system's introduction is fully assessed and confirm a validation strategy is developed and managed to deliver all associated requirements to a high-quality standard and within pre-agreed timelines.
    • Validation Plans
    • Validation Protocols – including Traceability Matrices
    • Validation Summary Reports
    • Periodic Review Reports
    • Discovery Studies
  • Compile and co-ordinate the approval of validation documentation including:
  • Coordinate and support the execution of validation testing.
    Ensure issues are addressed / escalated in a timely manner to minimize
  • Ensure any CAPA / Follow-up items assigned to you are actioned in a timely manner or that an Addendum is submitted if it is not possible to complete in line with the target completion date.
    Maintain Aries with up-to-date project status details. any delays to projects.
Qualifications:
 
Required Experience / Education:
  • Associates Degree (Levels 1 and 2)
  • 1 year of general work experience (Level 1)
  • 1 year of related validation/testing experience (Level 2)
Preferred Experience / Education:
  • Bachelor’s Degree (Levels 1 and 2)
  • 1 year working within an established pharmaceutical quality system (e.g., QA, Validation, or software testing role)
  • GxP regulations
  • Practical knowledge of validation and related activities
What Almac Group can offer YOU!
  • Full medical, vision & dental benefits the 1st of the month after start date
  • 20 days of PTO to start plus 12 holidays per year
  • Company paid long and short term disability along with life insurance
  • 401k company match
  • Professional development programs/ continuous learning opportunities
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Almac is an exceptional, award winning, drug development solutions provider at the forefront of the pharmaceutical industry.  We are a privately owned organization that has organically grown over 50 years now employing almost 5,600 highly skilled personnel worldwide. Our US Headquarters is located at Souderton, PA with additional operations scattered around the US and Europe. ‘Partnering to Advance Human Health’ is more than just a tagline – it is our way of life.
Embracing diversity is at the heart of enhancing Almac Group’s unique culture and reflects our fundamental belief that all people deserve equality, inclusivity and the opportunity for advancement. We are committed to cultivating a welcoming, supportive, and inclusive environment for all.  Together, we will build on the strength in our diversity and deliver exceptional solutions to advance human health globally.
 
RECRUITMENT AGENCIES PLEASE NOTE: Almac will only accept applications from agencies/business partners that have been invited to work on this role through our portal. Candidate Resumes/CV’s not submitted through our portal or directly to Hiring Managers will be considered unsolicited and no fee will be payable. Thank you for your cooperation.
 
Almac Group, Inc. is an Equal Opportunity Employer - Minorities/Women/Protected Veterans/Disabled - Proudly embracing diversity in all of its expressions.
 
 
Almac provides reasonable accommodations to people with disabilities who need assistance completing the application process.  Please email us at [email protected] to request assistance.

 
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