QA Validation Engineers - Durham, United States - Hamlyn Williams

Description

We're working with a renowned global pharmaceutical company who focus on developing drugs, vaccines, and biologic therapies. With a strong emphasis on innovation and research, they are addressing critical health needs such as cancer and infectious diseases.

As part of the Global Digital & Data Quality team, you will collaborate with stakeholders (e.g., System Owners, Process Owners, Data Owners, Business Unit, Technical Units and Subject Matter Experts) to assess and remediate legacy systems and evaluate/implement new computerized systems, which enable GxP business processes. This includes:

• Ensuring Technologies selected meet the high-level business needs while encouraging innovation and efficiency.
• Interfacing with Corporate Global IT and other internal & external entities to align GxP shopfloor, laboratory, quality system and/or infrastructure technology capabilities/solutions with quality policies and objectives.
• Ensuring the initial project tailoring is appropriate for the complexity and risk to accommodate the full scope of work.
• Providing the independent quality approval of key qualification/validation documentation such as policies, procedures, acceptance criteria, plans, protocols, specifications, reports and computerized system related changes to ensure compliance to company standards and applicable regulations throughout the computerized system lifecycle (including changes /modifications /deviations /variances /compliance investigations).
• Assuring at-site/above-site system owners have Operating Level Procedures/Plans in place, and are routinely followed to ensure that computerized system(s) remain in a validated status (e.g., problem and incident management, change control, periodic review, investigations, backup/restore, System Use and Administrative SOPs (including sufficiently detailed electronic data review/audit trail review instructions for users), disaster recovery plans, business continuity plans).
• Reviewing processes and supporting documentary evidence to verify that compliance activities related to computerized systems are in place and effective.
• Promoting GxP awareness and a culture of continuous improvement and facilitating manufacturing process improvements, laboratory operational excellence and validation activities, including latest trends in validation and best practices.
• Representing Digital & Data Quality upon request in local site or system specific project meetings.
• Providing Quality Unit review/approval of SDLC documentation.

To be considered for this position, you will require:

Qualification:

• Bachelor's degree. Preferably Information Technology, Engineering or equivalent.

Experience:

• Hands-on experience and understanding of automated systems supporting pharmaceutical manufacturing, IT infrastructure and/or laboratory operations.
• At least two (2) years of experience in delivering validated IT solutions or an application support role.
• Good understanding of the current pharmaceutical industry and applicable regulations (FDA/EU/ICH), with emphasis in Data Integrity, 21 CFR Part 11, 210, 211 and 820 and local regulatory expectations.
• Must demonstrate working knowledge of the principles, theories and concepts of computerized system validation / compliance.
• Familiarity or practical experience in the implementation of quality systems in a pharmaceutical, laboratory, or biotechnology manufacturing environment.
• Limited supervision required in day-to-day activities.

Out client is offering this position on a 6 month contract with options to extend for 12-18 months. Hybrid working is available with 2 days offered WFH per week.