Associate Manager -Quality Assurance

• This Pfizer Quality Operations position will support the Pharm Sci Small Molecules QO department by performing Quality Assurance activities associated with the Procedure Administrator, Documentation and Records Management team member. Activities may include analytical method validation review/approval, instrument/equipment qualification, investigations, change control, SOPs and ensuring adherence to regulatory and internal compliance standards at the Pfizer Indian Institute of Technology Madras Research Park (IITMRP).  The candidate will partner with key business lines to provide QA GMP guidance and support.  The candidate should possess sufficient knowledge of cGMP and have a knowledge of scientific principles.

  
  

  
  Location: Colleague will be based in IITMRP Chennai and follow a flexible working program of onsite and remote work.

  
  

  ROLE RESPONSIBILITIES & SKILL SETS:

  
  
  • Provides administration of the procedural documents in support of commitments, business, or project needs in a timely manner. Supports the management of PharmSci Active Library and other documentation systems for Business lines.
  • Partners with Business Lines in the development, implementation, and management of their documentation and records to ensure ALCOA principles are adhered to as part of the documentation lifecycle.
  • Awareness on DI and ALOCA principles.
  • Basic understanding cGMP requirement like 21 CFR part 11,210 and 211 and ICH guidelines.
  • Maintaining the compliance at labs and during review of documents.
  • Must have good communication and convincing skills.
  • Well-disciplined and Self-motivated attitude.
  • Participate in the implementation of new initiatives and goals within QA function and with business line partners to drive consistency, efficiency, and compliance.
  • Manage own time to meet agreed targets and develop plans for work activities on own projects within assigned teams.
  • Suggest improvements and conduct continuous improvement activities.
  • Contribute to the development and compliance of quality and business line partner procedures.
  •  Provide support to Inspection Readiness efforts, internal audits & regulatory inspections as needed.
  • Practice and encourage quality culture behaviors within quality and the business lines.
  • Should have good command on MS office operation -Excel, word and PowerPoint presentation preparation.

  • QUALIFICATIONS :

    
    

    Education:

    
    

    Master of science in chemistry

    
    

    Master of pharmacy in QA or chemistry

    
    

  • Relevant experience:

    
    

    Relevant work experience in document management and procedure administration in healthcare

    
    
    
  Work Location Assignment: Flexible

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.