Specialist QA
Apply NowCompany: Puerto Rico Professionals Development Group
Location: Puerto Real, PR 00740
Description:
15th July, 2024
Summary
Perform one or more of the following duties and responsibilities in support of Quality Assurance program under minimal supervision.
Requirement
Summary
Perform one or more of the following duties and responsibilities in support of Quality Assurance program under minimal supervision.
Requirement
- Doctorate degree or Master's degree and 3 years of directly related experience or Bachelor's degree and 5 years of directly related experience or Associate's degree and 10 years of directly related experience or High school diploma / GED and 12 years of directly related experience.
- Perform review, approval and tracking of cGMP processes, procedures, testing (methods) in manufacturing, documents and records, batch record review, MES, EBR, SAP, Trackwise; including but not limited to Deviation's, CAPAs, and validations.
- Actively engage in Continues Improvement initiatives, programs, and projects.
- Vigilant ensuring that changes that could potentially impact product quality are assessed according to procedures.
- Certify that MES / EBR change control and new implementations complies with stablished procedures and specifications following current procedures.
- Ensures that production records, MES /EBR testing validation process results are completed, accurate, and documented according to written procedures and cGMP regulations.
- To be successful, you will require strong collaboration and partnership cross functionally to ensure the Quality Management System processes are executed in accordance with established procedures.
- Strategic advisor to senior management of quality, compliance, supply, and safety risks.
- To be fully engage in communication plan and maintain Management updated with progress of the project in Work Center Teams, Daily Meetings and in Quality systems forums.
- Supports internal/external audits and inspections as part of the audit/inspection management team including acting as Quality unit representative as needed.
- Accountable for assigned training adherence to permit execution of required tasks.
- Champion Continuous Improvement initiatives and projects.
- Provides support to Digital MES automated teams and provide quality oversight judgement during discussions.
- Validated expertise in Quality Systems such as Non-Conformance, CAPA, and Change Control.
- Experience in computer systems validation or computer systems quality assurance (medical device and/or consulting background technical proficiency).
- Robust knowledge of and experience with processes involved in manufacturing and distribution, QA, QAL, Process Development and validation.
- Experience with Validation of GxP applications, Validation Master Plan, Installation Qualification (IQ), Risk Assessment/GxP assessment, Operational Qualification (OQ), and Performance Qualification (PQ) Protocols, Test Scripts, and Completion/Summary Reports approvals as per the compliance requirements.
- Validated experience as Quality Contact for complex projects involving document simplification.
- Validated experience in Commissioning and Qualification.
- Strong organizational skills, including ability to follow assignments through to completion.
- Enhanced skills in leading, influencing and negotiating.
- Demonstrate ability to interact with regulatory agencies.
- Solid word processing, presentation, database, and spreadsheet application skills.
- Strong communication (both written and oral) Spanish and English, facilitation and presentation skills.
- Proven skill in working independently and to effectively interact with all levels throughout the organization.
- Advanced data trending and evaluation.
- Ability to evaluate compliance issues.