Onsite Quality Compliance & LIMS Specialist (GMP)

Amaris Consulting; Latina; On-site; EUR 24,000 - 36,000; Full time

Benefits offered by this job

Meal vouchers

Flexible working options

Health insurance

Job summary

Amaris Consulting is seeking a Quality Compliance & LIMS Specialist for an onsite role in Latina. You will define and maintain LIMS specifications for GMP materials and products, collaborating with QC, QA, Manufacturing and clients to translate requirements into LIMS records.

The ideal candidate has 2+ years of LIMS experience in GMP pharma, knowledge of EU-GMP and pharmacopoeias, and strong English skills (B2+). Italian fluency or high proficiency is expected.

Qualifications

• 2+ years of LIMS-related experience in GMP pharma
• Knowledge of LIMS, EU-GMP, 21 CFR Part 210 & 211, ICH guidelines
• English at B2 or above; Italian native/C2 level
• Degree in Chemistry or related field

Responsibilities

• Define and maintain LIMS specifications for GMP materials and products
• Collaborate with QC/QA/Manufacturing and clients to translate needs into LIMS records
• Prepare specifications for cleaning validation activities in LIMS
• Implement analytical testing reduction programs in LIMS
• Set up and maintain stability study plans in LIMS
• Assess raw material requirements against pharmacopoeial monographs
• Review analytical methods, tests and acceptance criteria
• Support change controls, data reviews and GMP docs

Skills

Attention to detail

Cross-functional collaboration

English proficiency

Education

Degree in Chemistry or related field

Tools

LIMS

Job description

Amaris Consulting is seeking a Quality Compliance & LIMS Specialist for an onsite role in Latina. You will define and maintain LIMS specifications for GMP materials and products, collaborating with QC, QA, Manufacturing and clients to translate requirements into LIMS records.

The ideal candidate has 2+ years of LIMS experience in GMP pharma, knowledge of EU-GMP and pharmacopoeias, and strong English skills (B2+). Italian fluency or high proficiency is expected.