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About TSR:

TSR is a relationship-based, customer-focused IT and technical services staffing company.

For over 40 years TSR, Inc. and its wholly owned subsidiary, TSR Consulting Services, have prospered in the Information Technology staffing business, earning the respect of companies both large and small with well refined candidate screening, timely placement, and a real understanding of the right skill sets required by our clients.

Mission & Vision

We do not believe in building a vision around the company but building a company around our vision, which is simply;

Every employee’s voice matters, their effort is appreciated, and their talent is rewarded.

We challenge each employee daily, to raise the bar on how we treat our consultants and candidates. For far too long in this industry, candidates have been ghosted, lied to, or placed at a client and then forgotten about. Each day our staff works tirelessly at qualifying and placing, top talent with our clients, in a compassionate and caring manner.

Not every candidate is a match for the job, but every candidate and consultant will be treated with respect and professionalism.

Principal Quality Assurance Validation Specialist – Computer Systems

Job Description

  • Location: Devens, MA
  • Type: Contract
  • Job #74772

Our client, a leading pharmaceutical company, is hiring a Principal Quality Assurance Validation Specialist – Computer Systems consultant on a contract basis.

Work Location
Devens, MA/Hybrid

Summary

Highly experienced computer systems validation professional with strong compliance mindset.
Role will support the validation of computerized systems, including, but not limited to, process automation systems (DeltaV), manufacturing execution systems (MES), databases, Analytical Equipment, and IT infrastructure.

Detailed Position Responsibilities
• Oversee the qualification of process automation systems, Analytical and manufacturing instruments, manufacturing execution systems, databases, and IT infrastructure.
• Interface with MS&T, Validation, and end user groups as a Quality subject matter expert to provide technical validation guidance related to GxP compliance, design and requirements development, software testing, system administration, data management, and risk-management.
• Support the implementation and maintenance of Computer System changes, aligning with site compliance policies and procedures.
• Review and approve qualification protocols and test scripts, user acceptance testing, reports, change management, and authorization for use documentation.
• Ensure that all regulatory and cGMPs compliance items related to validation are satisfied.
• Review and approve exceptions associated with the qualification and participate in resulting investigations and correction / corrective action planning.
• Verify compliance with applicable client Policies, Guidelines and Directives and ensures consistency with site procedures and/or specifications.

Desired Experience and Education:
• Knowledge of science generally attained through studies resulting in a Bachelors Degree in a scientific or engineering discipline.
• A minimum of 6 years experience in an environment governed by cGMPs, in a computer systems validation or quality assurance validation role overseeing electronic equipment and computerized systems validation
• Detailed knowledge of cGMP and regulatory requirements for validation of equipment, computerized systems, and processes.
• Firm understanding of quality systems
• Proficiency in the use of computers and software applications including electronic validation documentation systems (such as ValGenesis and ALM)
• Demonstrated interpersonal, communication, and motivation skills.
• Must be action-oriented, customer-focused, and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, and analytical thinking.
• Knowledge of manufacturing executions systems such as Syncade and distributive control systems such as DeltaV is required
• Knowledge of applicable business systems including: Veeva Vault is desirable
• Effective written and verbal communication skills Development Value
• Interface with many functional areas including Manufacturing Science and Technology, Digital Plant, Manufacturing, Validation.

Pay:  70
 

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