Senior Associate, Change Control

Jobinhalt

Reports to: Associate Director, Change Control

The Senior Associate, Change Control handles assessing and managing internal Change Requests, as well as assessing and progressing any changes proposed by SteriMax suppliers affecting SteriMax product or systems, to closure, and in line with business requirements (e.g., batch release, launch or product manufacturing.) This individual is highly organized and uses time management and organizational skills to face changing priorities and meet assigned due dates.

Responsibilities:

Change Control Responsibilities

• Work with SteriMax suppliers to review and assess external change requests, in a timely manner.
• Work with the change requestor to initiate local change controls and manage the execution of change, including tracking progress against the required due date.
• Progress electronic change control records and track the status of open change
• Assess change risk and impact of proposed changes, as per ICH Q9 and internal SOPs, based comprehensive rationales, justifications, supporting documentation and implementation plans.
• Follow-up on change task closures including leading various tactical change control
• Reviews and approves complex documents such as batch records, GMP protocols, process, cleaning validation documents, pertaining to pre- and post-commercialized products.
• Provides training to internal team and business, as assigned.
• Prepares and presents key quality metrics for presentation in various forums (weekly team meetings, Site Quality Council, etc.)
• Leads quality-based initiatives at both documentation and process-levels to optimize SteriMax’s operations and programs. Ensures ongoing improvement of established procedures and adherence to new systems/processes and compliance with regulatory requirements.
• Performs added duties as assigned.

Job Requirements:

• Minimum bachelor’s degree in science (Chemistry or Life sciences) or equivalent experience
• 8 plus years of QA experience in the pharmaceutical industry; previous experience working in a GMP manufacturing environment (sterile experience and working knowledge of sterile GMPs, preferred
• Working experience and expertise with quality systems i.e., Change Control, Deviations, CAPA,
• Well-developed organizational and time management skills; project management skills are an asset.
• Experience supporting regulatory and customer inspections.
• Experience working with electronic QMS systems.
• Working knowledge and application of GMPs, ICH guidelines and other relevant guidelines and regulations
• Ability to effectively work both independently and in a team environment.
• Proficient in computer skills as a business tool, specific work experience using Microsoft applications (Word, Excel, PowerPoint). Knowledge of application software such as Trackwise, SAP, preferred.
• Project management skills are an asset.
• Effective communication in English (oral and written)

• Well-developed organizational and time management skills; p project management skills are an asset.