Our client, a Giant pharmaceutical industry has immediate openings for QA IT Specialist;
- As part of the QA IT team and reporting to the Associate Director of QA IT
- Responsible for 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.
- Ensuring Technologies selected meet the high-level business needs while encouraging innovation and efficiency.
- Interfacing with IT and other internal & external entities to align GMP shop-floor, laboratory, quality system and/or infrastructure technology capabilities/solutions.
- 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.
- Assuring site/above site system owners have Operating Level Procedures/Plans, approved by Quality, in place and routinely followed to ensure 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, disaster recovery plans, business continuity plans).
- 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.
- work 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.
- 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.
Min 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 (FDA/EU/ICH), 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 / compliances.
- Professional Certifications (e.g. Six Sigma or certification in Project Management (PMP) added adv.
- 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.
12months Contract renewable basis with attractive packages!
Interested applicants, please kindly submit latest resume to; email@example.com (R1110894)
Yen Leng Yap EA License No. 02C3423 Personnel Registration No. R1110894