Job Description

ROLE SUMMARY

• Responsible for reviewing documents related to product development, analytical data (including electronic data, chromatographic data, and audit trails), as well as instrument and equipment qualification
• Accountable for ensuring data integrity compliance and adherence to SOPs during the review of both hard copy and electronic records
• Conduct periodic system audit trail reviews and ensure compliance with 21 CFR Part 11 requirements
• Liaise effectively with global BL and OQ colleagues to achieve organizational objectives
• Maintain a thorough understanding of ICH quality guidelines and relevant regulatory guidance on microbiology method development pertaining to sterility, BET, CCIT, and associated development requirements
• Possess in-depth knowledge regarding sterility requirements and filter validation activities in accordance with PDA technical reports
• Demonstrate familiarity with requirements for sterile ANDA product development and combination products
• Exhibit strong proficiency in MS Office applications, including Excel, Word, and PowerPoint presentation preparation

ROLE RESPONSIBILITIES & SKILL SETS

• Awareness of DI and ALOCA principles
• Basic understanding of cGMP requirements, including 21 CFR part 210 and 211, ICH guidelines, and sterile product requirements
• Maintain compliance in laboratories and during document review
• Ability to perform statistical evaluation and analysis of analytical data during method development and validation review
• Effective communication skills.
• Adherence to discipline and self-motivation.
• Participate in the implementation of new initiatives and goals within the QA function and with business line partners to support consistency, efficiency, and compliance.
• Manage time to meet agreed targets and plan work activities for projects within assigned teams.
• Suggest improvements and participate in continuous improvement activities.
• Contribute to the development and compliance of quality and business line partner procedures
• Provide support for inspection readiness efforts, internal audits, and regulatory inspections as required

QUALIFICATIONS
Education:

• Master of science in chemistry
• Master of pharmacy

Relevant experience:

• Relevant work experience in an analytical data review and Technology transfer and cGMP pharmaceutical sterile manufacturing area

Location: On premise
Work Location Assignment: On Premise
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Quality Assurance and Control

Skills Required