Change Control Specialist

Change Control Specialist


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  • Full Time
  • Delhi
corrective, preventive action, equal employment opportunity

Job Description

You will be a member of Pfizer s dedicated and highly effective quality assurance and control team. You will be responsible for activities involved in developing and maintaining quality programs, processes and procedures that ensure compliance with established standards and agency guidelines. Your contribution in quality risk management will help us in commitments tracking, interpreting policies, manage site complaints and work directly with operating entities to provide process analyses oversight. Thanks to you, we will be prepared for all upcoming audits and inspections. You will be relied on to ensure that the quality assurance programs and policies are maintained and modified regularly. You will make sure that there are uniform standards worldwide and best practice sharing, which will help in fostering the achievement of the companys mission globally.

As a Senior Associate, your knowledge and skills will contribute towards the goals and objectives of the team. Your focus and ability to meet team targets will help in completing critical deliverables. Your innovative use of communication tools and techniques will facilitate in explaining difficult issues and establishing consensus between teams.

It is your hard work and focus that will make Pfizer ready to achieve new milestones and help patients across the globe.

How You Will Achieve It
Contribute to the completion of complex projects, manage own time to meet agreed targets and develop plans for work activities on own projects within a team.
Evaluate applicable corrective and preventive action responses to the audit findings for adequacy and timeliness.
Ensure Quality Assurance Auditing policies and procedures are kept up to date and aligned with Pfizer Quality standards and Regulatory requirements.
Prepare and participate in Manufacturing and Supplier Quality Assessment Audits
(MSQA) and BOHs Inspections to the site, ensuring successful results, and timely

implementation/closure of action plans, identify and manage routine Customer Quality complaints for commercial Drug Products in global complaints management system (PCOM) and interactions with the Contractor Quality organization if needed for ensuring that the investigation reports are appropriate and acceptable.

Assist Quality Control lab Supervisor with technical issues involving injector functionality, component testing, and protocol execution.
Contribute to quality assurance management team initiatives and objectives.
Assist in the process of gathering, interpreting and applying statistical methods to various Production/Quality related processes and communicate those through reports, memos, files and presentations.
Implement and adhere to {Current} Good Manufacturing Practices {part of GxP} regulations and company policies.
Conduct detailed audit testing in connection with the investigation of allegations of expense report fraud, conflicts of interest, and other violations of Pfizer policies and procedures or laws.
Assist in the review of area documentation and perform trend analysis on data, controls and standards.
Bachelors Degree
3 years experience
Demonstrated experience and skills in conduct and documentation of quality investigations related to pharmaceutical / medical device manufacturing processes
Strong knowledge and understanding of Quality System functions, manufacturing / packaging processes, validations, engineering drawings and basic statistical processes
Ability to understand and apply towards Quality Engineering tasks, mathematical concepts especially as it relates to statistics and probability
Good technical writing skills, and communication as well as presentation skills
Working knowledge of Microsoft Office, Microsoft Project, Statistical Software.
Masters degree
Complaint investigation experience
Experience with electronic laboratory systems
Other details
Department:Quality (QA-QC)Industry:Pharma / BiotechSkills:corrective, preventive action, equal employment opportunity, continuous improvement facilitation, writing skills, trend analysis, quality system, quality controlEducationOther (Other)

Recruiter detailsCompany Name: PFIZER LIMITEDCompany Description:
Pfizer is a leading research-based biopharmaceutical company. We apply science and our global resources to deliver innovative therapies that extend and significantly improve lives. We make medicines and vaccines that help people when they are sick and prevent them from getting sick in the first place, as well as some of the world’s best-known consumer healthcare brands. Every day, our colleagues work in developed and emerging markets to treat, cure and eradicate life-threatening conditions and challenge some of the most feared diseases of our time. Pfizer also collaborates with healthcare providers, governments and local communities to support and expand access to reliable, affordable healthcare around the world. For more than 150 years, Pfizer has worked to make a difference for all who rely on us.