QA IT Specialist
Our client is a US MNC and a giant Pharmaceutical company. They are currently looking for motivated individuals to join them in an exciting career journey.
- Responsible for the quality aspects of GMP computerized systems/equipment and the supporting infrastructure used in site facilities, utilities, manufacturing, packaging, labelling, and laboratories to ensure compliance with company policies, procedures and regulatory expectations.
- Involvement in all quality-related activities for computerized systems which are required for impact on product quality, patient safety or data integrity.
- Working closely with stakeholders and SME's from site operations, quality operations, IT, automation and engineering to provide evidence of quality oversight throughout the computer system lifecycle and facilitate continuous improvement.
- Conduct their function and roles independently, with integrity, fairness, and objectivity to protect products and patients.
- Collaborating with stakeholders (e.g. System Owners, Process Owners, Data Owners and Technical Unit) to assess and select computerized systems which enable GMP business processes.
- Providing the independent quality approval of key qualification /validation documentation such as policies, procedures, acceptance criteria, plans, protocols, requirements, 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).
- Reviewing processes and supporting documentary evidence to verify that compliance activities related to computerized systems are in place and effective.
- Supporting regulatory inspection and audit activities as needed. This includes the review of audit or inspection reports, responding to findings related to IT applications, automated manufacturing equipment, automated lab systems and infrastructure (at local sites) and taking appropriate actions to ensure GMP compliance.
- Bachelor's degree. Preferably in Science, Information Technology, Engineering or equivalent.
- Hands-on experience and understanding of automated systems supporting pharmaceutical manufacturing, IT infrastructure and/or laboratory operations.
- 5 years of experience in regulated pharmaceutical manufacturing industry.
- At least 3 years of experience in delivering validated IT solutions or an application support role in a regulated environment.
- Strong understanding of the current pharmaceutical industry and applicable regulations with emphasis in 21 CFR Part 11, 210, 211, and 820 and local regulatory expectations.
- Must demonstrate extensive knowledge of the principles, theories and concepts of computerized system validation / compliance.
- Familiarity and practical experience in the implementation of quality systems in a pharmaceutical, laboratory, or biotechnology manufacturing environment.
- Limited supervision required in day-to-day activities.
- Professional Certifications (e.g. Six Sigma or certification in Project Management (PMP)
- Good understanding of applicable Engineering and/or Laboratory or Standards related to computerized systems development, implementation & Operations
- Hands on experience in a Quality and/or Compliance role in a GMP environment
*Please note that this is a contractual role.
If you're interested, please do kindly send in your detailed and updated CV to Tammy Chew Wen Hui (R1877573) at email@example.com and I'll reach out to you for a brief confidential chat.
Tammy Chew Wen Hui EA License No.: 02C3423 Personnel Registration No.: R1877573