Validation Coordinator

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Pfizer

Pfizer

at

Pfizer

Location

Karachi, Pakistan

Date Posted

June 7, 2021

Category

Pharmaceutical

Job Type

Full-time

Education Requirement Bachelors/Masters
Career Level Mid Level
Experience 2-3 Years
Base Salary Competitive Salary
Street address Karachi
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Description

Why Patients Need You

Everything we do, every single day, is consistent with an unwavering dedication to the standard and the supply of protected and efficient merchandise to sufferers. Our science and risk-based compliant high quality tradition is versatile, progressive, and buyer oriented. Whether you might be concerned in improvement, upkeep, compliance or evaluation via analysis packages, your contribution will straight affect sufferers.

What You Will Achieve

You might be a member of Pfizer’s devoted and extremely efficient high quality assurance staff. You might be accountable for analysis, evaluation and approval of validation grasp plan, protocols and stories. Your methodological strategy will assist us guarantee compliance of our high quality programs with firm requirements and authorities regulatory necessities. Your

problem-solving skill will assist us troubleshoot validation issues for tools and efficiency processes and conduct statistical evaluation of testing outcomes and course of anomalies. Your documentation abilities will information the writing, evaluation and approval of for validation course of paperwork and technical stories associated to tools, merchandise and processes.

As an affiliate, your deal with the job will contribute in attaining mission duties and targets. Through your area information and dedication, you’ll create a collaborative staff atmosphere to your colleagues.

It is your arduous work and dedication that may make Pfizer prepared to realize new milestones and assist sufferers throughout the globe.

How You Will Achieve It

Contribute to the completion of advanced initiatives, handle personal time to satisfy agreed targets and develop plans for work actions on personal initiatives inside a staff.
Determine course of functionality of latest tools via execution of authorised protocols and guarantee outlined parameters are included into respective working procedures and batch data.
Assists with improvement of validation protocols and handle Regulatory queries and responses.
Participate in deviation investigations to determine root causes and outline corrective and/or preventative actions.
Adhere to all firm and Good Manufacturing Practices {additionally cGMP} procedures, together with security rules throughout the plant and participates in developments of validation packages as wanted to stay present with cGMPs and business.
Work successfully as a member of the Quality Operations (QO) Good Manufacturing Practices {additionally cGMP} coaching staff in addition to straight with Business Area Training Leads / Coordinators and SMEs inside Quality to help Good Manufacturing Practices {additionally cGMP} and web site coaching initiatives.
Report to the Validation Section Manager, the Validation Engineer will guarantee that tools, amenities, and utilities are validated in accordance with {Current} Good Manufacturing Practices {a part of GxP} rules, regulatory necessities, and firm insurance policies and requirements.
Work on summarization of information into concise stories that’s reviewed by the QO product skilled and authorised by manufacturing and high quality administration.
Define issues, acquire information, set up info, and draw legitimate conclusion.
Work in a staff atmosphere to satisfy all staff goals and talk progress on scheduled initiatives.

Qualifications

Must-Have

Bachelors (Pharma) / Pharm-D / MSc Chemistry
Min 1 12 months expertise in pharmaceutical business
Excellent consideration to element and dealing information of Food and Drug Administration Regulations/Guidance, and Good Manufacturing Practices
Excellent organizational abilities, and skill to deal with altering deadlines
Strong communication with written and verbal abilities
Working information of Microsoft Office, particularly Excel for analysis of information

Nice-to-Have

Technical writing expertise
Pharmaceutical Industry with laboratory course of validation expertise
Working information of kit qualification and calibration particularly for laboratory tools

Pfizer is an equal alternative employer and complies with all relevant equal employment alternative laws in every jurisdiction wherein it operates.

Quality Assurance and Control

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