QA Validation Specialist - Thorofare, United States - Synectics

Description

Execute and/or approve deliverables for the Site Validation Plan enabling overall strategic implementation of remediation and qualification activities within the site's commitments.

Work in close collaboration with site-based SMEs to ensure the implementation of robust, high-quality deliverables, with clear alignment between inspection SMEs and site leadership.

Review and approve actions related to facility, computerized systems, laboratory or products.
Ensure proper assessment with respect to Qualification and Validation is conducted.
Performs QA oversight for Validation and Qualifications activities for Manufacturing, QC and other GMP support areas.

Review and approval of deviations / non-conformances and lead the strategic discussion for investigations with respect to operations or validation related matters.

Support the site's Inspection Readiness program for regulatory inspections, baseline audits /audits.
Actively drive high quality deliverables at the site by promoting a high standard of Quality Culture.
Helps build and drive a culture of compliance throughout the organization.
Inspire change management initiatives and embed collaboration forums across the sites and as required with stakeholders.
Control project scope to limit schedule changes and to capture changes of scope that may arise.

Requirements

B.S. degree in Science, Engineering or related field with 5 years' relevant experience; OR
MSc with 3 years of relevant experience.

5 years of experience in Pharmaceutical Manufacturing preferred, at least 3 years combined of relevant experience in quality-based roles including experience in GMP and/or laboratory operations required.

Proven track record and practical experience in establishing and maintaining quality systems, in facility changes and validation as well as successfully managing authority inspections from major HA's.

In-depth knowledge of cGMP's, especially FDA regulations 21 CFR Parts 11 with preferred understanding of regulations for computerized systems
Strong understanding and operating awareness of working in a pharmaceutical company.
Experience in regulatory agency and partner/collaborator inspections.
Good understanding of local/National Health Authorities regulations and standards
Demonstrated ability to problem solve and mediate complex issues.
Project management capabilities preferred.
Strong communication, leadership and team working skills
Effective in prioritizing, shows the appropriate sense of urgency around prioritized tasks.
Flexibility and ability to prioritize and manage multiple tasks simultaneously
Creative thinker in ways in which we can ensure better compliance and systems (A risk-based approach to Quality and Compliance)
Demonstrated excellence in written and verbal communication.
Ability to effectively communicate at all levels in the organization - oral and written
Demonstrated ability to work cross-functionally
Highly motivated, driven and have a passion to be part of a fast-paced team

Benefits


Healthcare Insurance:
Synectics offers eligible employees and their dependents healthcare coverage through BlueCross BlueShield of Illinois.

Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.

Premiums are subsidized by Synectics.


Dental Insurance:
Synectics offers eligible employees and their dependents a dental plan through MetLife.

Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.

Vision Insurance:
Synectics offers eligible employees vision insurance through VSP.

Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.

401(k)

Plan:
The Synectics Inc. Investment Savings Retirement Plan.

Synectics offers all employees who are 21 years of age or older the opportunity to invest in the 401(k) Plan on the first enrollment date that is at least 30 days after employment begins.

Enrollment dates are each January 1st, April 1st, July 1st, and October 1st.


Technical Certification Bonus:
Synectics is pleased to award its employees a bonus of up to $500 for an approved professional certification.

In determining the bonus amount, Synectics will consider the cost of the test(s) for any certification relating to your current position, achieved during your employment with us.

Only one Certification Bonus per calendar year may be awarded per employee. Only current, active employees will be eligible to receive this bonus.

It will be awarded 90 days after the Synectics office has received documentation confirming the successful completion of the certification.

Synectics is an equal opportunity employer.
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