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Urgent! Quality Engineer Job Opening In Worcester – Now Hiring Katalyst HealthCares & Life Sciences

Quality Engineer



Job description


Responsibilities:

  • Ensure proper integration and support of quality regulations: drug, biologics, device and/or combination products.

  • Assist project teams in planning, preparation, review and approval of quality documentation.

    Responsible for implementing and maintaining the effectiveness of the quality system for drug, biologics, device and/or combination products including compliance with Corporate policies, processes and procedures.

  • Apply effective quality systems, procedures and/or processes within cross functional teams to ensure compliance as well as efficiency throughout our quality system.

  • May be required to prepare and present data during regulatory audits (FDA, EMA, Anvisa, etc) and internal audits.

  • Support the interrelated function activities including design control with R&D, Manufacturing Science and Technology (MS&T), Supply Chain, Program Management, Commercial, Medical, Pharmacovigilance, and Regulatory Affairs.

  • Coordinate quality system elements, training, continuous improvement, and tactical support across functions, plants, and affiliates.

  • Support new product introduction for pharmaceutical products, medical devices, or combination products.

  • Support design changes to existing medical devices and combination products.

  • Interact with internal and external partners for development of best practices in our quality systems and procedures.

  • Perform assessments to determine compliance to processes and regulations to identify potential gaps and mitigate and implement improvements within our quality system.

  • Oversee the implementation and management of training and education programs for various aspects of quality assurance.

  • Requirements:
  • years relevant experience.

  • BS Degree.

  • Pharmaceutical products, medical devices, combination products and biologics.

  • This role will support the strategic direction to ensure business objectives are met.

  • Specific areas of support may include the Product QA, Manufacturing QA, Supplier/Incoming QA, Process Qualification/Validation, Compendia management and CAPA.

  • This position will ensure that all product, process or system related quality activities from raw material inspection through shipment of final product are following local, Corporate, and governmental regulations.

  • Focus on process qualification PPQ support and review activities on range of topics from process controls to raw material controls.

  • Familiarity with sap, oracle (Inventory management).

  • Will support biologics products (not small molecule products).

  • QA/QC review background.

  • Manufacturing or quality control exp.

  • working with managers in PQA team.

  • Batch records.

  • Overseeing manufacturing process of biologics.

  • Process qualification protocols.

  • yrs exp needed.

  • Document review.

  • Pharma driven candidate needed.

  • Familiarity with Track wise or Veeva exp is a plus.

  • Familiarity with biologics manufacturing (Biologics industry exp needed).

  • Exp with validation documents (process validation documents, method validation documents).

  • Exp with document review and associated skills with that.



  • Required Skill Profession

    Engineers



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      Unlock Your Quality Engineer Potential: Insight & Career Growth Guide


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