Pfizer Data Entry Jobs Work From Home
Job Details:-
Hiring Organization:- Pfizer
Industry:- Private
Employment Type:- Full Time
Work Hours:– 8 Hours
Locations:- UK
The Manager, Auditor is responsible for the delivery and execution of the global Quality Assurance (QA) program audit activities on assigned GCP portfolio/programs/entities. This role is responsible for GCP Oversight and for assuring the compliance of projects, products and programs 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
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- Assesses compliance of GCP clinical trial sites and processes against ICH GCP and applicable global regulations
- Independently conducts more complex routine/non-routine investigator site audits, support process audits, and manage/lead 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 GCP working knowledge and is called upon to resolve issues based on knowledge of relevant SOPs (Standard Operating Procedures), GCP regulations and guidelines, as well as local regulations
- Works with RQA colleagues on cross GCP audit plans as required. Collaborates with colleagues across RQA and auditees from different functional lines and/or vendors within Pfizer.
- Provides clients with recommendations and influences to meet the changing business need with support from Manager
BASIC QUALIFICATIONS
- BS (or equivalent), preferably in pharmaceutical or natural sciences, or equivalent
- Demonstrates knowledge of ICH GCP and global regulations
- 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 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
- Experience evaluating and understanding quality standards or their application
- Suggests new audit techniques and new controls
- Acts as SME in specific specialty (e.g. gene therapy, non-interventional studies, 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
About the Pfizer Company :
Pfizer Inc. is a prominent global pharmaceutical company headquartered in New York, USA. Its United Kingdom subsidiary, Pfizer UK, plays a critical role in the company’s operations, contributing significantly to research, development, and the commercial distribution of Pfizer’s products. Pfizer UK has established itself as a key player in the British pharmaceutical industry, focusing on innovative treatments across various medical fields, including oncology, immunology, cardiology, and infectious diseases.
Pfizer UK operates from its main office in Walton Oaks, Surrey, and has additional sites in Sandwich, Kent, and Cambridge. These locations are integral to Pfizer’s research and development (R&D) efforts. The Sandwich site, in particular, is renowned for its significant contributions to drug discovery and development, housing advanced laboratories and employing a substantial number of scientists and researchers. Cambridge is another vital hub, leveraging its proximity to leading academic and research institutions to foster innovation and collaboration.
One of the landmark achievements of Pfizer UK is its pivotal role in the development and distribution of the COVID-19 vaccine, Comirnaty, in collaboration with BioNTech. This mRNA-based vaccine has been instrumental in the global fight against the COVID-19 pandemic, demonstrating Pfizer UK’s capacity for rapid and large-scale vaccine production and distribution.
Pfizer UK is also dedicated to corporate social responsibility, engaging in numerous community and healthcare initiatives across the country. These include partnerships with healthcare providers, support for medical education, and initiatives aimed at improving public health.
In addition to its focus on R&D and community engagement, Pfizer UK adheres to stringent ethical standards and regulatory compliance, ensuring that its operations meet both local and international guidelines. This commitment to excellence and ethical practices reinforces Pfizer UK’s reputation as a leader in the pharmaceutical industry.