Validation & Engineering Group Inc V⪚ a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical Biotechnology Chemical Food and Medical Devices industries in the following areas Laboratory Compliance Computer Engineering Project Management Validation and other services We are seeking a talented dedicated individual committed to work under the highest ethics standards for the following position Quality Assurance QA Specialist III Description The Senior Product Quality Assurance PQA Analyst has various objectivefunctions related to Third Party Manufacturing TPM plants and PQA functions During routine operations the Senior PQA Analyst is responsible for supporting the day to day Quality Assurance activities related to the TPM plants including but not limited to approval of manufacturing direction to the production floor review and approval of manufacturing laboratory and raw material investigations assess product impact analysis and corrective and preventive action for events review and approval of changes as applicable The Senior PQA Analyst also is responsible to evaluate supplier change notification monitor process track and trending and perform annual Product Quality Reviews This person also acts as a liaison between company regulatory areas and TPM plants for regulatory submission
Responsibilities
- Maintains an effective liaison and cooperative relationship with other Areas including but not limited Quality Regulatory Technical Supply Chain along with the TPM sites
- Ensures that bulk drug substance andor drug product production at TPM sites is performed as per current good manufacturing practices according to local procedures and as per specifications and manufacturing directions provided by QA Operations
- Ensures TPM procedures including but not limited to raw material specification product specification test methods supplier change notification shipping are in compliance with cGMP policies regulatory approvals and Qualit

📌 Quality Assurance (Temuco)
🏢 Pinnaql
📍 Temuco