Careers

Job Posting: QA Team Lead, Change Control, Facilities/Equipment and Qualification

Indianapolis, IN
Full Time

Position Overview

Administers and leads site-wide effort of generating change controls, overseeing the change control system, managing change controls and providing critiques, guidance and direction to all departments so that audit defensible change controls are developed and documented. Responsible for QA oversight of Facilities/Equipment and related qualification activities and QA review/approval of associated documents.

Major Position Activities & Responsibilities

• Provides QA oversight of change management process for modified equipment, processes, procedures, products, facilities and utilities.
• Responsible for review of change controls and validation activities around equipment and process improvements and changes, engineering studies, and manufacturing/packaging development.
• Collaborates and provides direction on change controls and documentation requirements for all types of change controls (equipment, test methods, manufacturing process, etc.) to all site personnel; serves as facility's change control subject matter expert.
• Manages the systems and processes for change control and coordinates evaluation of proposed changes on regulatory filings, compliance, quality, outcomes and processes in manufacturing and packaging operations. Assembles individuals required for preparing/completing timely and thorough change control documentation, and oversees change
  control process to successful completion.
• Responsible for continuous development of current change control system, including proposals for change of governing procedures.
• Compiles and assesses change control metrics, effectiveness of change controls, and risk associated with change control initiatives
• Provides QA oversight for maintenance and qualification activities for equipment, facilities, and utilities. This includes review and approval of Critical System Work Orders and qualification documents.
• Responsible for identifying improvements in equipment, facility, and utility maintenance and qualification and working with cross-functional groups to implement improvements.
• As needed, compiles data and authors reports that are submitted to regulatory agencies in support of product licenses and applications.

Scope

This position is responsible for smooth operation of the facility's change control system and QA review and approval of Facilities/Equipment and Validation documentation. Although the position has no direct supervisory responsibility, it must influence and direct actions on the part of all departments involved in the change control process.

• Position requires Bachelor's degree in biology, chemistry, pharmacy or other life sciences. Graduate level degree preferred.
• Previous experience with change control process/management of change controls.
• Direct experience authoring/editing/executing and/or approving validation documents for equipment/facilities/utilities including FAT, IQ 00, PQ and change controls
• Minimum 10 years pharmaceutical industry experience required in a technical or Quality role
• Familiarity with FDA, EU and ICH GMP requirements and guidances, ISPE Applied Risk Management for C&O, ISPE Science and Risk Based Approach for the delivery of facilities, systems and equipment and ICH 8, 9, 10 - Knowledge of Risk management and Risk Analysis Tools
• Experience with sterile drug products and biopharmaceuticals preferred.
• Proven ability and skill in analyzing, understanding, and presenting technical data.
• Experience in technical writing and communicating across organizations functions and organizational levels is expected.