Are you ready to join a world leader in the exciting and dynamic fields of the Pharmaceutical and Medical Device industriesPQE Group has been at the forefront of these industries since 1998, with 40 subsidiaries and more than 2000 employees in Europe, Asia and the Americas.
Due to a constant growth, PQE is looking for ahighly motivated CSV Technical Lead to join our team in Singapore. The resource will provide support in activities related to Audit Trail Review and Periodic Review, ensuring compliance with applicable regulatory requirements and internal procedures.
You will be responsible for:
- Support and perform Audit Trail Reviews in accordance with company policies and regulatory standards.
- Support and execute Periodic Reviews of computerized systems to ensure continued compliance and validated state.
- Collaborate with Quality, IT, and Business functions to collect, assess, and document relevant data during review activities.
- Ensure proper documentation of findings, deviations, and corrective/preventive actions (CAPAs) where necessary.
- Provide support during internal and external audits/inspections concerning computerized systems compliance.
- Maintain up-to-date knowledge of CSV regulations, GxP requirements, and industry best practices.
Requirements:
- Bachelors degree in Engineering, Life Sciences, Computer Science, or a related field.
- Minimum of 5 years in Computer System Validation (CSV) or related compliance role.
- Familiarity with Audit Trail Review and Periodic Review processes.
- Good knowledge of GxP, 21 CFR Part 11, Annex 11, and other applicable regulatory requirements.
- Strong analytical, organizational, and documentation skills.
- Ability to work effectively both independently and within cross-functional teams.
- Fluency in English (written and spoken).
Nice to Have:
- Previous experience in the pharmaceutical or life sciences industry.
- Experience supporting audits and inspections.
About you:
- Strong knowledge of Computer System Validation (CSV) principles, methodologies, and regulatory requirements (GxP, 21 CFR Part 11, Annex 11).
- Experience supporting Audit Trail Reviews and Periodic Reviews of computerized systems.
- Ability to prepare, review, and maintain validation documentation in compliance with industry standards.
- Skilled in identifying, documenting, and mitigating risks through deviations, CAPAs, and change control processes.
- Detail-oriented with excellent analytical and problem-solving skills.
- Effective communication and interpersonal skills to collaborate with IT, Quality, and Business functions.
- Ability to work independently while managing multiple priorities in a regulated environment.
- Strong organizational skills with the ability to meet deadlines under pressure.
- Fluency in English (written and spoken).
- Singapore Permanent Residency or Citizenship is a mandatory requirement for this position.
First project you will assigned to:
Location: Singapore
Availability: Full on site
Next Steps
Upon receiving your application, if a match is found, the Recruiting department will contact you for an initial HR interview.
If there&aposs a positive match, a technical interview with the Hiring Manager will be arranged.
In the case of a positive outcome coming from Hiring Manager interview, recruiter will contact you for further steps or to discuss our proposal.
Alternatively, if the outcome is negative, we will contact you to halt the recruitment process.
Working at PQE Group
As a member of the PQE team, you will be part of a challenging, multicultural company that values collaboration and innovation. PQE Group gives you the opportunity to work on international projects, improve your skills and interact with colleagues from all corners of the world.
If you are looking for a rewarding and exciting career, PQE Group is the perfect place for you.
Apply now and take the first step towards an amazing future with us.
