QC Systems Specialist (GMP, LIMS, Comp Systems Validation (CSV), CI, Pharma)

QC Systems Specialist (GMP, LIMS, Comp Systems Validation (CSV), CI, Pharma)

Our client is searching for an experienced Quality Control Validation Lead to join their QC computer systems validation team. As a QC Lead, you will be responsible for day-to-day administration, validation and qualification of laboratory instrumentation and software at the site. Additionally, this position may assist other teams in the QC Laboratory Operations team such as Stability, Sample Management, Technology Transfer, and Data Integrity teams.

Key responsibilities:

1. Ensures data integrity by following regulatory requirements and policies pertaining to analytical instruments and computer software applications. Completes QC analytical instrument and software validation deliverables, writes GMP procedures, validation documents, and executes test scripts. Approves final project documents and writes final validation summary reports.
2. Acts as leader for other team members. Writes, reviews and approves QC analytical instrument and software validation project plans. Independently drives projects to on-time completion. Collaborates and prioritizes with other QC leaders to ensure agreed upon timelines are met.
3. Software administration responsibilities include conversion of test methods, batch records and other written source documents into instrument computer system software.
4. Leads team and performs technical, root-cause analysis for complex system issues or errors and completes recommended solutions. Performs user and application software administration on Enterprise systems. Works on troubleshooting assignments that are complex in nature where considerable judgment and initiative are required in making creative and effective recommendations to solve problems. Completes system audit trail reviews, monitors back-ups and performs validation maintenance on systems.
5. Recommends and implements analytical instrument and software engineering controls for QC Laboratories. Ensures data integrity and IT/OT security by configuring computer operating systems and application security policies, file/folder permissions, data back-up scheduler, instrument parameters and method templates. May be ACSV SME during regulatory and customer Inspections and Audits.
6. Performs all aspects of QMS processes – Change Control, Deviations, CAPAs, Tasks. Writes, reviews, assesses, and/or approves change controls for analytical instruments and software used in QC laboratories and manufacturing.

Key requirements:

1. Min Bachelor or Master’s Degree. Preferred area of study in Microbiology, Biochemistry, Chemistry or Related Science Fields (Computer Sciences).
2. Working experience within a regulated cGMP industry is a must.
3. Experience working in Quality Control Laboratory or enterprise computer systems and GMP Quality Systems such as TrackWise, LIMS, iLAB, MODA, C3ME, and Empower would be an advantage.
4. Significant experience in Analytical Laboratory testing (e.g., protein purification and characterization, protein chromatography, SDS-PAGE, Western blotting, amino acid analysis, TOC, Bioburden, Endotoxin, Elisa, Flow cytometry, Microbiology).
5. Project management experience is preferred to independently drive projects to on-time completion.

If you are interested in the position, do kindly drop your most updated resume to leonleong@recruitexpress.com.sg (Attn: QC Systems Specialist).

Thank You.

Leon Leong De Cong
R1551708
Recruit Express Pte Ltd (Healthcare & Lifesciences Division)
EA License: 99C4599