Oferta pracy

Regulatory Quality Assurance GMP Audit Manager

Pfizer O firmie

Pfizer

Żwirki i Wigury 16B

Warszawa

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Regulatory Quality Assurance GMP Audit Manager (EU multiple)Numer ref.: 108013

ROLE SUMMARY

Science is the foundation of all that we do at Pfizer. We are seeking a Manager, Auditor who will join a diverse team of dedicated professionals driven to significantly improve the lives of patients through his/her/their work at a company whose culture is committed to developing and nurturing diverse talent so that each colleague has the opportunity to build a fulfilling career.

Regulatory Quality Assurance (RQA) is an independent Quality audit function within the Compliance division, accountable to identify risks and non-compliance associated with Pfizer's GMP regulated operations.

The GMP Manager, Auditor is responsible for the delivery and execution of the global Quality Assurance (QA) program audit activities on assigned GMP portfolio/programs/entities. This role is responsible for GMP Oversight and for assuring the compliance of projects, products and programs with Pfizer Standard Operating Procedures (SOPs), policies, and all applicable worldwide regulations , guidelines and standards (e.g., US FDA, EU Directives, National regulations, ICH, ISO).

ROLE RESPONSIBILITIES

  • Independently plans/leads more complex audits of material suppliers, service providers and Pfizer Country Offices, participates in audits of low complexity commercial/clinical manufacturing sites and contracts manufacturers, performs initial, routine and for cause audits, and manages/leads with minimum oversight
  • May engage with more complex audits including process audits or serve as a reviewer of low complexity, outsourced audits
  • Supports and executes on quality programs related to functional areas, specific vendor entities and/or assessments
  • Has GMP working knowledge and is called upon to resolve issues based on knowledge of relevant SOPs (Standard Operating Procedures), GMP regulations and guidelines, as well as local regulations and standards
  • Works with RQA colleagues on cross GxP audit plans as required
  • Ability to manage multiple stakeholders to synthesize feedback and take action with support from Manager

BASIC QUALIFICATIONS

  • BS (or equivalent), preferably in pharmaceutical or natural sciences, or equivalent
  • Demonstrates solid working knowledge of local/major regulations, business concepts and quality operations
  • Ability to think critically to identify and assess areas of greatest risk and develop a strategic approach to audit based on compliance and business knowledge
  • Understands quality and auditing frameworks and application
  • Exhibits proficient organizational and project management skills
  • Demonstrates technical writing skills
  • Ability to identify trends within data and apply insights to make recommendations
  • Understands Regulatory environment with the ability to interpret and apply regulations
  • Actively identifies areas to assess for greater risk to support senior auditor positions in driving outcomes
  • Ability to synthesize information and draw conclusions
  • Suggests new audit techniques and new controls
  • Specializes in at least one conventional technology (e.g., API, solid oral dosages)
  • Experience evaluating and understanding quality standards or their application

PREFERRED QUALIFICATIONS

  • At least 5 years of experience in audits related to good manufacturing practices audits and at least 3 years of hands on experience in production or laboratory environments ( manufacturing, packaging, testing and distribution of drug products, active ingredients and medical devices)
  • Knowledge of core regulations governing the auditing space (EU cGMPs, World Health Organization, FDA, Global Regulations, etc.)
  • Exhibits working knowledge of data analytics and interpretation capabilities (Excel, PowerPoint, etc…)
  • Fluent English
  • Additional Fluent in Europe language as a plus
  • Work authorization/immigration requirements: EU citizenship or permission to work in EU

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

  • The travel requirement may be approx. 40%

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