Quality Site Head

Dallas, TX 75201

Posted: 05/15/2024 Job Category: QA Analyst Tester Job Number: 2876

Job Description

Quality Site Head

Quality Site Head Job Description:
Manufacturing Quality Assurance work includes:
  • Defining and specifying activities, processes, and standards to fulfill the quality requirements for a manufactured material, component, or product
  • Building and maintaining the infrastructure and systems necessary to consistently ensure the timely delivery of quality products
  • Auditing, monitoring, and determining the quality of manufacturing processes and/or outputs against defined internal and regulatory standards Reporting and troubleshooting manufacturing process deviations and defects in finished goods
Quality Site Head Essential Functions:
    • Ensure review and approval of Quality and Manufacturing SOP's, BOM's and Master Documents.
    • Coordinate with other members of the management's operating team in the day-to-day conduct of the site's business.
    • Ensure approval and monitoring of all Manufacturing suppliers, vendors and contract manufacturers, including company REFS Services as applicable.
    • Maintain the laboratories in a validated state and, along with Materials, Manufacturing and MS&T heads, maintain the plant in a validated state.
    • Ensure proper approved testing procedures for raw materials, bulk products, finished products, packaging components and critical systems are in place and followed.
    • Ensure tracking, evaluation and reporting of key performance indicators (e.g., on time release, etc.,) to determine need for corrective and preventive actions.
    • Monitor product performance via customer feedback and internal performance data and assure systems are in place for continuous improvement.
    • Monitor fiscal performance, report trends, and take timely corrective actions as required.
    • Serve as Management / Deputy Management representative responsibilities as applicable.
    • Provide a safe working environment for associates, contractors, and visitors.
    • Ensure compliance with Health Safety and Environmental standards at all levels of the organization.
    • Ensure associates have tools and equipment needed to perform their jobs safely and effectively Strategy and Direction
    • Setting: Develop and implement procedures and methods to ensure that the Quality unit and the Manufacturing unit are in compliance with GMP's, Corporate Standards and other applicable regulatory standards.
    • Assist, develop and implement solutions to improve quality, demonstrate ongoing control and increase cost efficiency.
    • Ensure optimal alignment with other site functions in terms of targets and metrics and direct QA/QC teams towards higher performance levels.
    • Ensure the organization has appropriate succession and associate development plans.
    • Ensure organization is staffed with well qualified, trained, and forward focused individuals to assure continuous improvement and compliance with internal and external regulatory standards.
    • Coordinate proactively with other facilities and division functions to assure appropriate levels of involvement, guidance, and direction.
    • Ensure compliance with regulations (e.g. 21 CFR 210 /211 and Medical Device Regulation 2017/745) and established standards (ISO/EN ISO 13485:2016)

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Job Requirements

Aseptic, Engineering, Manufacturing, Manufacture Validation, Formulation, SOP, BOM, Pharma, Quality

Meet Your Recruiter

Sam Slonkosky
Technical Recruiter

I'm happy to connect with you on your next career challenge. Whatever your needs are, we at Resolution Technologies promise to provide unrivaled quality and service. Please don't hesitate to contact me if you have any questions about this position.

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