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This role requires employees to be fully vaccinated against COVID-19 as a condition of employment.
location: North Billerica, Massachusetts
job type: Permanent
salary: $110,000 - 115,000 per year
work hours: 9 to 5
This is a key technical role responsible for Quality oversight on Computer System Validation GMP systems. Including but not limited to author, review and approve validation documentation, and strategic planning, maintaining compliance of computerized operations in a GMP environment. The position will primarily focus on the implementation of a new Enterprise Resource Planning (ERP) system. In additional, the position will provide QA support to GMP information systems and software applications in areas of QMS, laboratory, manufacturing and clinical information management systems and computerized instrumentation.
- QA CSV Lead for the ERP implementation, focus on SAP will be a plus.
- Oversee the development, and approval, of computer system validation documents, including validation plans and protocols, test scripts for the SAP implementation
- Accountable for initiation/preparation and closeout of all CSV related change control documents and quality events.
- Implement appropriate validation methodologies as per company procedures in collaboration with Business and system owners.
- Work with overall project manager to include validation activities in implementation timelines
- Review and analyze the user and functional requirements using risk-based approach.
- Evaluate proposed changes to validated computer systems and recommend level of validation activities required
- Support the identification and qualification of all computer systems which impact cGMP operations using a risk-based methodology
- Author and/or review validation documentation - such as user requirements, functional requirements, configuration specification, Validation Master Plan (VMP), IQ/OQ/PQ documentation, GxP criticality assessments, Electronic Records Electronic Signature (ERES) assessments, Data Integrity (DI) assessments, test scripts, trace matrix requirements, deviations, validation summary reports, and system use documentation (system admin, user admin procedures).
- Oversee the decommissioning of GMP software systems.
- Work closely with IT and business owners to ensure appropriate validation of cGMP computer systems
- Coordinate audits of internal computer systems validation activities, protocol and procedures
- Support and execution of a risk-based clinical quality audit plan for assigned programs
- Duties may include internal compliance or efficiency improvement efforts within CSV department.
- Ensure that SOP's and procedural methodologies employed to maintain the validated state are reviewed and updated as needed.
- Provides active role in the continuous improvements of CSV processes and methodologies as per current regulations.
- 3 - 5 years of CSV experience in FDA regulated industry- focus on ERP / SAP
- 2+ years pharmaceutical/Life Sciences manufacturing industry experience
- 2+ years in computer systems validation, process validation, QA or compliance functions
- BS degree in Computer Science or Life Science
- Excellent understanding and experience with current industry regulations, standards, guidelines, and practices.
- Good knowledge of quality systems and quality events
- Good knowledge and understanding of 21 CFR Part 11 as well as regulations around GCP, GLP and GMP.
- Good communication/interpersonal skills
- Good writing skills for validation documentations and SOPs
skills: SOP, Quality Assurance, GLP (Good Laboratory Practice), CRFs, GCP (Good Clinical Practice), GMP (Good Manufacturing Practice), ERP System
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.