Quality Assurance (QA) Specialist III

Validation & Engineering Group; Temuco; Presencial; CLP 25.000.000 - 40.000.000; Jornada completa

Descripción de la vacante

Validation & Engineering Group is seeking a Senior Product Quality Assurance PQA Analyst to support TPM plants and PQA functions, reviewing manufacturing directions, investigations, CAPA, and changes to ensure CGMP compliance.

The ideal candidate has a Bachelor's degree in Engineering or Science and at least six years in pharmaceutical operations, with GMP knowledge, strong analytical skills, and experience with SAP/LRMS; ability to communicate across multicultural teams.

Formación

• Bachelor's degree in Engineering or Science is preferred.
• GMP regulations and standards affecting pharmaceutical products.
• Strong analytical skills and attention to detail.
• Technical writing skills and investigations processes.
• Ability to communicate across all levels and multicultural audiences.

Responsabilidades

• Review and approve manufacturing directions to the production floor.
• Provide support to PQA in global projects and events, including risk analysis and implementation.
• Evaluate supplier change notification, monitor process, and perform annual Product Quality Reviews.

Conocimientos

GMP knowledge

Analytical skills

Technical writing

Investigations

Interpersonal communications

Educación

Bachelor's degree in Engineering or Science

Herramientas

SAP

LRMS

Descripción del empleo

Validation & Engineering Group Inc V&EG 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 IIIDescription

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 sitesEnsures 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 OperationsEnsures 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 Quality Technical Agreement with TPM siteReview and approve manufacturing directions to the production floorProvide support to PQA in global projects and events to ensure intended results are achieved; including planning risk analysis and implementation

Qualifications Bachelors degree preferably in Engineering or ScienceSix years of experience within the Pharmaceutical operations preferably Biologic manufacturing processKnowledge of GMP regulations and standards affecting pharmaceutical productsComprehensive knowledge and application of business and quality conceptsStrong analytical skills and attention to detailChange plan Exception Reports SAP and LRMS experience is highly preferredProven ability to adapt communication style for a variety of modes as well as for multicultural audiencesStrong interpersonal relations communications skills Ability to effectively communicate across all levels of the organizationAssures the quality of manufactured products and processes per standard operating processesSOPS and GMP Good Manufacturing PracticesTechnical Writing skills and investigations processes

Available to work extended hours possibility of weekends and holidays

At Validation & Engineering Group people always come first We believe that when youre empowered to do your best work bold ideas thrive and real progress happens This isnt just a job its an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose driven supportive team Excited to build something meaningful together We look forward to hearing from you

Validation & Engineering Group is an equal opportunity employer

All applicants will be considered for employment without regard to race color religion sex sexual orientation gender identity national origin veteran status or disability status