Job Description - SNFIJP00002576 - USA-Compliance Specialist II (Manufacturing/Quality) in Swiftwater
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SNFIJP00002576 - USA-Compliance Specialist II (Manufacturing/Quality)

Ref: US_EN_6_971649_1343212

Posted on 08 July 2020
Job Location
Swiftwater, Pennsylvania
Contract Type
Contractor
Category
Engineering

One of the top Pharmaceutical Manufacuters in Swiftwater, PA is looking to hire a Compliance Speciaist to join the team!

The compliance specialist will have these priorities listed:

Priority 1 - Continued Process verification. Evaluate Sites and harmonize practices based on the global CPV documentation

Priority 2 - Process Criticality Assessment (from Quality by Design Principles). Evaluate sites and harmonize practices based on global QbD documentation

Priority 3 - Support global validation document revision

Priority 4 - Implementation of a risk-based approach for validation phase 2 PPQ.

Assist in organizing the priority task force meetings

Assist in performing the sites evaluation and assessments

Assist in the identification of the necessary remediation for each site

Follow up on action and ensure deliverables are met on time

Alert in case of roadblock or delays.

Provide input in validation document reviews.

Assist in organizing monthly review meeting with the Validation CoE members.

Requirements:

- Engineer/master degree, with 5+ years in quality validation.

  • Risk-based approach / ICHQ9 mindset
  • Vaccines & Biotech Processes understanding/knowledge
  • Methodology ability
  • High level of autonomy
  • Excellent communication skills, able to manage cross functional communications
  • Leadership during workshops / Experience in understanding customer's voice and quality requirements is a must

f you are interested in this Compliance Specialist in Swiftwater, PA then please click APPLY NOW. For other opportunities available at Modis Engineering and Technology go to www.modis.com.   If you have questions about the position, please contact Ray Sabio at 317-558-8868 or Raymond.Sabio@modis.com

Equal Opportunity Employer Minorities/Women/Veterans/Disabled

To read our Candidate Privacy Information Statement, which explains how we will use your information, please visit https://www.modis.com/en-us/candidate-privacy/   The Company will consider qualified applicants with arrest and conviction records.

Equal Opportunity Employer/Veterans/Disabled

To read our Candidate Privacy Information Statement, which explains how we will use your information, please

The Company will consider qualified applicants with arrest and conviction records

Apply

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