Job Summary:
- responsible for commissioning and qualification oversight for our automated and IT systems, to ensure our compliance to the company procedures, cGMP expectations and regulatory requirements.
Responsibilities:
- Provides expertise in performing Computerized Systems Validation.
- Primary personnel for the qualification of Computerized Systems including Automation Systems (PCS 7, EMS, MES) and GMP equipment qualifications operating within the framework of regulations (GxP, 21CFR11, etc.)
- Perform collaborative work with the Compliance Engineering team on other CQV activities.
- Coordinate with both internal and external teams (manufacturing, engineering, quality, vendors, contractors, etc.) to achieve the site objectives.
- Prepare, review, and approve of SOPs and qualification-related documentations (protocols and reports)
- Ensure that the qualification strategy is sound and adhere to company standards and regulatory requirements.
- Investigate deviations and write deviation reports and findings.
- Raise and follow-up change control records.
Requirement:
- Degree in Engineering/Science or related studies.
- Minimum of 8 years’ experience in pharma/ biotech manufacturing industry with at least 5 years in CSV activities.
- High level of understanding in Regulatory compliance
- Familiar with working in a GxP environment and keeping up to date with current GxP, with flexibility to change as needed due to new regulatory requirements and technologies, as relevant for clinical and commercial supply.
- In-depth knowledge in Computer System Validation (CSV), GAMP 5, 21 CFR Part 11, ER/ES, validation lifecycle, current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP) in a biotech facility
- Good knowledge of GxP, GDP, CQV approaches including Validation Lifecycle approach (URS, DQ, FAT/SAT, IOQ, CSV, Cleaning/ Thermal Validation etc.), regulatory requirements and best industry practices.
- Competent in technical writing and presentations. Proficient in MS Office Suite (Microsoft Word, PowerPoint, Excel).
- Problem solver and has ability to make decisions.
- Able to work independently, self-starter, self-motivated and task oriented.
- Good communication skills and able to openly communicate and escalate any relevant issues.
- Develop positive relationship with excellent interpersonal skills.
Reg No.: R2090579
EA License No.: 02C3423
Recruitment Consultant
Manpower Singapore
