We are seeking a highly motivated QC Systems Specialist with strong experience in pharmaceutical manufacturing environments. The ideal candidate will combine hands-on laboratory testing expertise with advanced skills in Quality Control (QC) systems, data management, and project execution. This role requires adaptability, cross-functional collaboration, and the ability to drive efficiency through digitalisation and automation initiatives.
Key Responsibilities
- QC Systems & Data Management
- Build, qualify, and manage QC data entities in LIMS/LMES systems to support laboratory operations and digitalisation projects.
- Support system migration projects (e.g., Labware, NEXTLab), ensuring smooth transition and data integrity.
- Develop automated trackers, spreadsheets, and queries (Excel, Google Sheets, SQL) to streamline QC workflows and reporting.
- Project & Stakeholder Management
- Collaborate with cross-functional teams, external vendors, and multi-site stakeholders to resolve issues and meet project timelines.
- Draft and maintain SOPs, technical documentation, and change management processes for QC systems and laboratory operations.
- Train and mentor team members on QC systems, laboratory techniques, and data management best practices.
- Continuous Improvement
- Identify workflow inefficiencies and implement automation solutions to reduce turnaround times and improve accuracy.
- Drive digitalisation initiatives to replace paper-based processes with electronic systems, enhancing productivity and compliance.
Qualifications
- Bachelor's Degree in Chemistry, Biological Chemistry, or related scientific discipline.
- 58 years of experience in pharmaceutical QC laboratories and/or QC systems implementation.
- Strong knowledge of LIMS, LMES, Empower, SQL, and Microsoft Office/Google Workspace tools.
- Hands-on experience in both chemistry and microbiology testing, with proven adaptability to new techniques and systems.
- Demonstrated success in managing QC system migrations, equipment qualifications, and digitalisation projects.
- Excellent communication and stakeholder management skills; ability to work across departments and external partners.
- Strong problem-solving skills, attention to detail, and ability to deliver under tight timelines.
Preferred Attributes
- Fast learner with aptitude for IT systems and digital tools.
- Proven ability to manage multiple projects simultaneously.
- Experience in training and mentoring junior staff.
- Strong work ethic, independence, and collaborative mindset.
