Senior QA Analyst - TPM & Regulatory Excellence

Pinnaql; Temuco; Presencial; CLP 27.900.000 - 42.408.000; Jornada completa

Descripción de la vacante

Validation & Engineering Group is a leading provider offering QA and engineering services across pharmaceutical, biotech, and medical device sectors. The Senior PQA Analyst supports day-to-day QA activities for TPM sites, reviews investigations, ensures cGMP compliance, and participates in global change processes.

The role requires a six-year background in pharmaceutical operations, strong analytical ability, and experience with change control and supplier notifications.

Formación

• Bachelor's degree in engineering or science.
• Six years of pharma operations experience.
• Knowledge of GMP regulations and standards.
• Strong analytical skills and attention to detail.

Responsabilidades

• Maintains an effective liaison with QA, Regulatory, Technical, Supply Chain and TPM sites.
• Ensures TPM production complies with cGMP and QA directions.
• Ensures TPM procedures including raw material and product specs and change notifications meet requirements.
• Review and approve manufacturing directions to the production floor.
• Provide support to PQA in global projects and events with risk analysis.
• Ensures investigations of TPM plant events are thorough and well-documented.
• Perform annual Product Quality Review according to global procedures.
• Participates in Trend Review Board to monitor process and trending.
• Participates in the Global Change Review Board as TPM representative.
• Generates change management plans for TPM plants including risk analysis.

Conocimientos

Analytical skills

Attention to detail

Communication skills

Educación

Bachelor's degree in Engineering or Science

Herramientas

SAP

LRMS

Descripción del empleo

Validation & Engineering Group is a leading provider offering QA and engineering services across pharmaceutical, biotech, and medical device sectors. The Senior PQA Analyst supports day-to-day QA activities for TPM sites, reviews investigations, ensures cGMP compliance, and participates in global change processes.

The role requires a six-year background in pharmaceutical operations, strong analytical ability, and experience with change control and supplier notifications.