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Associate Manager Quality Assurance

0 years

0 Lacs

Chennai Tamil Nadu India

Posted:6 days ago| Platform: Linkedin logo

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Skills Required

development data audit integrity compliance microbiology combination excel word powerpoint presentation evaluation analysis communication support consistency efficiency inspection audits technology manufacturing

Work Mode

On-site

Job Type

Full Time

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 premiseWork Location Assignment: On PremisePfizer 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

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