14 days old

Product Quality Sr. Specialist

Pfizer
Vizag
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**Why Patients Need You**



Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.



**What You Will Achieve**



You will be a member of Pfizer's dedicated and highly effective quality assurance and control team. You will serve as a primary contact for managing product defect complaints. You will address and expedite product complaints in accordance with the company's complaint policy while ensuring compliance with regulatory agencies. Based on the feedback received, you will be relied on to suggest modifications to the existing manufacturing and packaging processes. You will maintain unified product defect investigation operating procedures and provide technical expertise to optimize the complaint processing systems. Your proactive problem solving approach will ensure that all complaints investigated and handled as per company policy.



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 commitment that will make Pfizer ready to achieve new milestones and help patients across the globe.



**How You Will Achieve It**



Complaint Investigation:



+ Perform product quality complaint investigations in a timely manner to determine the root cause and recommend appropriate CAPAs.

+ Promptly assess the impact on product quality and patient safety due to the complaint defect. Evaluate and take necessary containment and corrective action.

+ Issue Notification to Management (NtM) for any issues related to product quality, compliance or market actions.

+ Assess the requirement of Field Alert Report and provide the required data for FAR submission.

+ Use various investigation techniques and tools to analyze the data critically to draw an inference in support of investigation.

+ Handle the complaints through electronic complaint management database.

+ Collate investigation reports as required from various cross-functional departments and conclude the complaint investigations.

+ Evaluate the complaint trend and take appropriate actions.

+ Assist and/or undertake investigations and apply relevant and necessary actions/systems to ensure appropriate levels of compliance.



Annual Product Quality Review (APQR):



+ Prepare, maintain, and adhere to the annual schedule for APQR

+ Co-ordinate with cross-functional team for supporting data and prepare the APQR summary report timely.

+ Trend and analyze the data to ensure product quality is maintained throughout the life cycle.



Other Job requirements:



+ Co-ordinate the execution of market action and maintain the record.

+ Support Internal/Customer regulatory audits.

+ Present the information/data/document as necessary for complaints and APQR during audit/inspection.

+ Provide data for complaint, field alert report metrics for site quality review as required.



**Qualifications**



**Must-Have**



+ MastersDegree in Pharmacy

+ 7+ years' experience, preferable in Sterile Manufacturing process

+ Knowledge of performing product complaint analysis and investigations.

+ Strong knowledge on APQR preparation.

+ Should have critical thinking and analytical skills.

+ Current regulatory compliance expectations (India FDA, USFDA, MHRA, EMEA, TGA etc.

+ Knowledge of various quality tools for investigations and hands-on experience in gQTS.

+ Should have good technical writing skills

+ Excellent organization skills and the ability to manage multiple priorities

+ Good collaboration, communication and interpersonal skills with local, regional and global colleagues

+ Proficiency in using System Application and Products, Microsoft Word, Excel, Power Point, Visio



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



Quality Assurance and Control



\#LI-PFE
Posted: 2021-06-01 Expires: 2021-07-02
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Product Quality Sr. Specialist

Pfizer
Vizag

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