Industry - Pharmaceuticals

Skills - cGMP

Job Type - Permanent

Description/PRIMARY RESPONSIBILITIES :

- Provide support and coordination for compliance and regulatory-related projects.

- Apply cGMP (Current Good Manufacturing Practice) concepts into validation and change control, supplier quality management, quality system documentation review, and Development and/or modification of quality systems and other cGMP processes.

- Create, prepare and review technical reports.

- Conduct internal and external/supplier audits.

- Perform activities supporting the supplier quality management program, including supplier evaluations, audits, vendor requests/inquiries, and supplier complaint follow-up.

- Interact with clients regarding compliance/regulatory issues.

- Maintain current knowledge base of existing and emerging regulations by developing cGMP/Compliance and/or Regulatory policies and training for staff.

- Conduct and/or annual product review activities.

- Coordinate, prepare and review regulatory filing submissions.

- Expected to cross-train in identified quality unit activities outside of the Compliance and Regulatory department in a supporting capacity.

QUALIFICATIONS

- Bachelor's degree in a scientific discipline or equivalent with 3+ years of QA and/or Regulatory experience in a cGMP/FDA regulated environment (sterile manufacturing (injectables) preferred).

- Technical writing experience is required.

- Working knowledge of cGMP (Current Good Manufacturing Practice) regulations, guidance, and general compliance expectations.

- Working knowledge of investigational techniques, including but not limited to root cause analysis, risk assessment, impact evaluation, and technical report writing.

- Experience with Supplier Quality Management programs and/or auditing is preferred.

- Knowledge of Common Technical Document (primarily Chemistry and Manufacturing Controls (CMC)) format, content, and filing requirements for US and EU. Other jurisdictions a plus.

- Must be a detail oriented team player with effective planning, analytical thinking, organization, and execution skills.

- Must have proficiency in the Microsoft Office Suite.

- Excellent communication skills with internal and external personnel is essential.

- Ability to work effectively at a fast pace with cross-functional departments and manage priorities to meet timelines.

- Working knowledge of cGMP data management systems (EDMS, Trackwise, and/or SAP) is preferred.

Contact - Heather Humphreys

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