ACS group has an immediate need for a 'Principal Quality Assurance Validation Specialist' with experience in the Pharmaceutical Industry. This is a 7 - month contract opportunity and is located in Devens, MA. Our client is a leading pharmaceutical company.
Please review the job description below:
- Quality Assurance Validation Specialist - Computer Systems
- cGMPs, in a computer systems validation
- Electronic validation & Documentation
Position: Principal Quality Assurance Validation Specialist - Computer Systems
Work Location: Devens, MA
Duration: 7 Months Contract
**Highly experienced computer systems validation professional with strong compliance mindset. Role will oversee the validation of computerized systems, including, but not limited to, process automation systems, manufacturing execution systems (MES), laboratory instruments, databases, and IT infrastructure.
Detailed Position Responsibilities
* Oversee the qualification of process automation systems, laboratory and manufacturing instruments, manufacturing execution systems, databases, and IT infrastructure.
* Interface with Engineering, Validation, and end user groups as a QA 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.
* Oversee the development, implementation, and maintenance of site procedures and policies for Computer System Validation, aligning with global policies and procedures.
* Review and approve validation plans, 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 and ensures Validation Master Plan (VMP) adherence.
* Review and approve exceptions associated with the qualification and startup of the Devens Cell Therapy Facility and participate in resulting investigations and correction / corrective action planning.
* Verify compliance with applicable XXX's Policies, Guidelines and Directives and ensures consistency with other site procedures and/or specifications.
* Knowledge of science generally attained through studies resulting in a Bachelor's Degree in a scientific or engineering discipline or its equivalent.
* A minimum of 9 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: SAP, LIMS, Maximo and Veeva Vault is desirable
* Effective written and verbal communication skills
Development Value * Gain experience in Cell Therapy start-up and operations
* Interface with many functional areas including Manufacturing Technology, Digital Plant, Manufacturing, Validation, Quality
Thanks and regards,
P: (+1) 303-481-5170
ABOUT ACS Solutions.
ACS Solutions is a global provider of information technology solutions, talent solutions and workforce management services. Our Industry vertical based domain expertise, passion for innovation, combined with the power of technologies in cognitive sciences, cloud computing, data sciences, product engineering, robotic process automation, machine learning, and block chain, helps clients envision, build and run their businesses more efficiently. Headquartered in the US, ACS Solutions has grown to over $1.2 BN.
ACS Solutions is a Certified MBE by the Georgia National Minority Supplier Development Council.
ACS solutions has multiple subsidiaries, each focused on the unique area of business:
- Analysts international Corporation (Staff Augmentation Services)
- The Ascent Services Group Inc. (Life Sciences Talent Solutions)
- HireGenics, (Payrolling, IC Compliance, & MSP Services)
- DATA Inc. (Information Technology- staffing)
Recent Awards and Recognitions:
- 6th largest IT staffing firm in the US. (Staffing Industry Analysts (SIA) 2019)
- Largest Minority IT Staffing Firm in the US. (SIA 2019)
- ClearlyRated® 2020 Best of Staffing award winner for providing remarkable service quality to our clients. This is our ninth consecutive win.
IT and Industry certifications:
- Microsoft Gold Partner: Application Development, Cloud Platform, Data Analytics, Data Center, DevOps, Data Platform
- AWS Managed Services Partner
- Google Cloud Partner
- ISO 27001:2013 Certified for Data Security
- ISTQB Gold Partner
- ISMS (ISO 27001:2017)
SOC2 Type II C