Key contributor to the regulatory process for submission of site changes that impact regulatory filings. This role may be designated a Site Compliance Network Member (SCNM). Role Responsibilities
- Collaborates with PGS SMEs, PharmSci or other transfer team, PMO and other stakeholders for authoring of Health Authority dossier content.
- Authors and reviews submission content and ensures alignment with Pfizer PQS and Health Authority requirements
- Creates and manages CMC templates specific to the McPherson areas and processes aligned with Pfizer PQS and Health Authority requirements
- Completes impact assessments on site change requests to determine potential for regulatory impact and completes regulatory change requests when impact has been determined. Ensures appropriate supporting documentation and rationale for change is included.
- Utilizes GDMS for authoring activities and support the site in accessing documents in GDMS as needed.
- Supports other site Quality functions such as annual product record review, etc. as assigned.
- Bachelor's Degree in Science, Engineering, or Business
- A minimum of 5 years of experience with a combination of Quality Control or Quality Assurance functional area and/or other GxP manufacturing experience
- Proven experience with GxP change management process
- Knowledgeable on ICH process validation and/or method validation, method transfer, and compendial verification
- Technical writing experience
- Working knowledge of regulatory process and requirements for post approval changes
- Good knowledge of English, spoken and written
- Bachelor's Degree in Microbiology, Chemistry or related science
- Experience using USP, EP and other compendia
- Proven experience authoring regulatory submission content
Sitting, standing, walking, ability to perform mathematical calculations, and ability to perform complex data analysis. NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Other Job Details:
- Remote, onsite, or flex schedule.
- Core business hours 8-5, occasional evening, weekend, and holiday work may be required.
- No routine Travel, occasional Travel 0-10%.
Last Date to Apply for Job: October 25, 2021
Eligible for Employee Referral Bonus: Yes
#LI-PFEPfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.Sunshine Act
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