We are currently developing an integrated ERP and pharmaceutical operations management platform for a pharmaceutical manufacturing client. As we advance the technical implementation, we are looking for an experienced pharmaceutical compliance professional to help bridge the gap between software engineering, pharmaceutical quality systems, and computerized system validation.
About the Role
We are seeking a knowledgeable GxP Compliance & Computerised System Validation (CSV) Consultant to support the design, review, testing, documentation, and validation readiness of our pharmaceutical ERP platform.
This role is ideal for a professional who understands pharmaceutical manufacturing processes and can translate GxP requirements into practical software controls, documented procedures, and verifiable system requirements.
The successful candidate will work closely with our software engineers, QA/validation team, and relevant pharmaceutical process owners.
Key Responsibilities
i. Advise on applicable GxP requirements and pharmaceutical computerised system controls.
ii. Review ERP workflows to ensure alignment with pharmaceutical manufacturing and quality processes.
iii. Support the development and review of User Requirements Specifications (URS), Functional Requirements Specifications (FRS), risk assessments, and validation plans.
iv. Guide the preparation and review of IQ, OQ, PQ, User Acceptance Testing (UAT), and associated validation documentation, as applicable.
v. Advise on data integrity, audit trails, electronic signatures, role-based access controls, segregation of duties, and document control.
vi. Review electronic batch records, manufacturing workflows, inventory traceability, quality management, deviations, CAPA, and change control processes.
vii. Help establish requirements traceability, test evidence management, and validation documentation practices.
viii. Identify compliance gaps, recommend corrective actions, and support the assessment of validation readiness.
ix. Contribute to SOP development, user training requirements, and procedures for maintaining the validated state of the system.
x. Collaborate with the technical team to translate regulatory and operational requirements into implementable software specifications.
Required Qualifications and Experience
i. Demonstrable experience in pharmaceutical manufacturing, Quality Assurance, Quality Systems, Regulatory Affairs, or a closely related GxP-regulated environment.
ii. Practical understanding of GMP and pharmaceutical quality management processes.
iii. Experience or demonstrable competence in computerized system validation and validation documentation.
iv. Familiarity with risk-based validation, requirements traceability, test protocols, and documented evidence.
v. Understanding of pharmaceutical data integrity and electronic records controls.
vi. Strong documentation, analytical, communication, and stakeholder management skills.
Desirable experience
i. GAMP 5 and risk-based computerized system validation.
ii. FDA 21 CFR Part 11 and EU GMP Annex 11, where applicable.
iii. ICH and PIC/S guidance relevant to pharmaceutical quality systems.
iv. ERP, MES, QMS, LIMS, EDMS, or electronic batch manufacturing record systems
v. Experience implementing, reviewing, or validating digital systems used in pharmaceutical manufacturing.
Engagement Arrangement
This is a project-based consultancy opportunity. The consultancy fee will be agreed with the successful candidate based on experience and availability.
How to Apply
Interested professionals should send their CV and a brief summary of their relevant pharmaceutical compliance and computerised system validation experience to [email protected] not later than 20th October 2026.
