Analytical / QC Technology Transfer Specialist

Fastnet; Munster; On-site; EUR 65,000 - 85,000; Full time

Job summary

Fastnet is seeking an Analytical / QC Technology Transfer Specialist for a 12-month contract in Tralee, Co. Kerry. You will own the analytical workstream for product transfers, focusing on method transfer and verification within a GMP environment.

The role requires 4+ years of QC/Analytical experience, familiarity with analytical method transfer/verification and ICH Q2 principles, and a degree in Chemistry, Biochemistry or Pharmaceutical Science. Sterile fill-finish experience is advantageous.

Qualifications

• Typically 4+ years’ QC/Analytical experience within GMP pharmaceutical environment.
• Experience in analytical method transfer or verification.
• Degree in Chemistry, Biochemistry or Pharmaceutical Science.
• Sterile fill-finish analytical experience is advantageous.

Responsibilities

• Own analytical method transfer/verification protocols and reports, working closely with QC.
• Liaise with sending-site analytical teams to secure method packages, reference standards and comparator data.
• Plan and track analytical method transfer activities alongside the wider product transfer schedule.
• Support analytical investigations and provide analytical input into FMEA/risk assessments.

Skills

QC/Analytical experience

Analytical method transfer

GMP pharmaceutical environment

Risk assessments (FMEA)

Education

Degree in Chemistry/Biochemistry/Pharmaceutical Science

Sterile fill-finish analytical experience advantageous

Tools

ICH Q2 knowledge

Job description

Analytical / QC Technology Transfer Specialist | 12-Month Contract | Tralee, Co. Kerry

Summary:

A 12-month contract opportunity in Tralee, Co. Kerry for an experienced QC/Analytical professional supporting a sterile pharmaceutical Technology Transfer programme. You’ll take ownership of the analytical workstream for product transfers, with a particular focus on analytical method transfer and verification.

Key Responsibilities:

• Own analytical method transfer/verification protocols and reports, working closely with QC.
• Liaise with sending-site analytical teams to secure method packages, reference standards and comparator data.
• Plan and track analytical method transfer activities alongside the wider product transfer schedule.
• Support analytical investigations and provide analytical input into FMEA/risk assessments.

Requirements:

• Typically 4+ years’ QC/Analytical experience within a GMP pharmaceutical environment.
• Experience in analytical method transfer or verification, with knowledge of analytical method validation/transfer principles such as ICH Q2.
• Degree in Chemistry, Biochemistry, Pharmaceutical Science or a related discipline; sterile fill-finish analytical experience is advantageous.