Quality Engineer

Company : Katalyst Healthcares & Life Sciences

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:

• 5 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.
• 5 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.

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