Senior QC Specialist (System Support)

ANTER CONSULTING PTE. LTD.; Singapore; On-site; SGD 70,000 - 90,000; Full time

Job summary

A leading consulting firm in Singapore seeks a qualified professional to oversee quality control laboratory equipment and ensure compliance with GMP and GxP regulations. The ideal candidate will have a Bachelor's or Master's degree and at least 5 years of experience in the pharmaceutical or biopharma industry, providing technical leadership and ensuring efficient processes in QC support. The role involves acting as a site representative and leading continuous improvement initiatives.

Qualifications

• Minimum 5 years of experience in Quality Control within the pharmaceutical or biopharma industry.
• Strong knowledge of GMP, GxP, and regulatory requirements.
• Hands-on experience in analytical method validation and laboratory equipment qualification.

Responsibilities

• Act as site representative in global Communities of Practice and Centers of Excellence.
• Maintain the Site Validation Master Plan for laboratory equipment.
• Lead continuous improvement initiatives in QC support processes.

Skills

GMP knowledge

GxP knowledge

Analytical method validation

Change control management

Cross-functional collaboration

Education

Bachelor’s or Master’s degree in Life Sciences, Chemistry, Engineering, or a related field

Tools

Digital laboratory systems

Job description

Key Responsibilities

• Act as site representative in global Communities of Practice (CoPs) and Centers of Excellence (CoEs), ensuring effective communication and alignment on analytical processes.
• Maintain the Site Validation Master Plan and procedures related to ALCM and CPV for GxP laboratory equipment, ensuring alignment with site Quality and Validation strategies.
• Oversee life cycle management of QC laboratory equipment, including qualification, maintenance, and obsolescence risk management.
• Lead compendial compliance assessments, method control trend reviews, and data evaluations; recommend method improvements as needed.
• Support annual product and method reviews and invalid assay trending programs.
• Ensure compliance of all QC lab equipment with GxP, GMP, and regulatory requirements.
• Develop and maintain metrics to monitor qualification activities and identify performance trends or issues.
• Oversee documentation and approval of qualification deliverables such as risk assessments, traceability matrices, and validation reports.
• Support regulatory inspections and audits, presenting relevant equipment and validation documentation.
• Lead continuous improvement initiatives in QC support processes and equipment management.
• Ensure implementation and maintenance of QC digital solutions, including data management and end-user administration.
• Provide technical leadership for major laboratory projects, validation/transfer protocols, and change control requests.
• Serve as technical system administrator for QC GxP computerized systems.
• Ensure all work complies with cGMP, HSE, and data integrity requirements.

Requirements

• Bachelor’s or Master’s degree in Life Sciences, Chemistry, Engineering, or a related field.
• Minimum 5 years of experience in Quality Control within the pharmaceutical or biopharma industry.
• Strong knowledge of GMP, GxP, and regulatory requirements.
• Hands‑on experience in analytical method validation, laboratory equipment qualification, and digital laboratory systems.
• Proven ability to lead investigations, manage CAPAs, and support audits/inspections.
• Excellent communication, documentation, and cross‑functional collaboration skills.