Job Description:

Job information Manager Auditor from the Company Pfizer, this latest Manager Auditor job vacancy is located in the city Sandwich located in the country United Kingdom . This latest job opening is open to job seekers who have the latest education / graduate Bachelor Degree . Job Vacancies in this Manager field have been opened and published up to the specified time.

Job Responsibility:

ROLE SUMMARY The GxP Manager, Auditor is responsible for the delivery and execution of the global Quality Assurance (QA) program audit activities on assigned GxP Vendors. This role is responsible for GxP Oversight and for assuring the compliance of Vendors with Pfizer Standard Operating Procedures (SOPs), policies, and all applicable worldwide regulations and guidelines (e.g. US FDA, EU Directives, ICH, and National regulations). ROLE RESPONSIBILITIES

• Assesses compliance of Vendors against applicable government agency GCP, Regulatory and Pharmacovigilance regulations and guidelines as well as Pfizer policies and procedures
• Independently conducts/leads more complex routine audits for at least one vendor type (e.g. study conduct, pharmacovigilance service providers), supports non-routine and vendor oversight process audits and manages/leads with minimum oversight
• May engage with more complex 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 GxP working knowledge (mainly GVP) and is called upon to resolve issues based on knowledge of relevant SOPs (Standard Operating Procedures), GxP regulations and guidelines (mainly GVP), as well as local regulations
• Works with RQA colleagues on cross GxP audit plans as required.
• Provides clients with recommendations and influence to meet the changing business need with support from Managers.

BASIC QUALIFICATIONS

• BS (or equivalent), preferably in pharmaceutical or natural sciences, or equivalent
• Demonstrates knowledge of at least one area and awareness of ICH GCP, EMA Pharmacovigilance Directives and applicable global regulation
• Demonstrates solid working knowledge of 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 skill
• 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.
• Experience evaluating and understanding quality standards or their application.
• Suggests new audit techniques and new controls.
• Acts as an SME within a discipline/specific vendor program (e.g. labs, data management, etc.)

PREFERRED QUALIFICATIONS

• Demonstrable experience (operational or auditing preferred)
• Knowledge of core regulations governing the auditing space (FDA, Global Regulations, etc.)
• Exhibits working knowledge of data analytics and interpretation capabilities.
• A Manager must have at least one specialized knowledge area or two minor specializations

Work Location Assignment: Remote Purpose Breakthroughs that change patients' lives... At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives. Digital Transformation Strategy One bold way we are achieving our purpose is through our company wide digital transformation strategy. We are leading the way in adopting new data, modelling and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience. Flexibility We aim to create a trusting, flexible workplace culture which encourages employees to achieve work life harmony, attracts talent and enables everyone to be their best working self. Let's start the conversation! Equal Employment Opportunity We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms - allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees. DisAbility Confident We are proud to be a Disability Confident Employer and we encourage you to put your best self forward with the knowledge and trust that we will make any reasonable adjustments necessary to support your application and future career. Our mission is unleashing the power of our people, especially those with unique superpowers. Your journey with Pfizer starts here! Quality Assurance and Control #LI-PFE

Keywords : Sandwich jobs

Closed Date : 2024-12-11