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 qualificationAccountable for ensuring data integrity compliance and adherence to SOPs during the review of both hard copy and electronic recordsConduct periodic system audit trail reviews and ensure compliance with 21 CFR Part 11 requirementsLiaise effectively with global BL and OQ colleagues to achieve organizational objectivesMaintain a thorough understanding of ICH quality guidelines and relevant regulatory guidance on microbiology method development pertaining to sterility, BET, CCIT, and associated development requirementsPossess in-depth knowledge regarding sterility requirements and filter validation activities in accordance with PDA technical reportsDemonstrate familiarity with requirements for sterile ANDA product development and combination productsExhibit strong proficiency in MS Office applications, including Excel, Word, and PowerPoint presentation preparation

ROLE RESPONSIBILITIES & SKILL SETS

Awareness of DI and ALOCA principlesBasic understanding of cGMP requirements, including 21 CFR part 210 and 211, ICH guidelines, and sterile product requirementsMaintain compliance in laboratories and during document reviewAbility to perform statistical evaluation and analysis of analytical data during method development and validation reviewEffective 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 proceduresProvide support for inspection readiness efforts, internal audits, and regulatory inspections as required

QUALIFICATIONS

Education:

Master of science in chemistryMaster 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