Associate Manager – Quality Assurance Opportunity at Pfizer

Pfizer QA Job For Microbiology – Associate Manager Vacancy

Pfizer QA Job For Microbiology – Associate Manager Vacancy. Pfizer is hiring candidates for an Associate Manager – Quality Assurance vacancy. Interested and eligible applicants can check out all of the details on the same below –

Job Title – Associate Manager – Quality Assurance

Job ID – 4839103

Location of Pfizer Vacancy – India – Vizag

What You Will Achieve

You will be a member of Pfizer’s dedicated and highly effective quality assurance team. You will evaluate and review Pfizer’s clinical and commercial batches of drugs. You will make sure that product and process documents match the specifications based on established sampling and statistical process control procedures. Your expertise will help in identifying deviations from established standards, in the manufacturing and packaging of products. In the relevant cases, you will approve investigations and change control activities to ensure compliance with configuration management policies.

As a Senior Associate, your knowledge and skills will contribute to 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

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

Core Responsibilities –

• Fully independent reviews of critical change controls and protocols associated to Microbiology
• Responsible for review & approval of documents as per current regulatory requirements.
• Assessment, approval & closure of change control related to Microbiology
• Conducting change control review board (CCRB) meeting with cross-functional team to assess the change before initiation in gQTS and present the critical change controls to the leadership team for it is adequacy.
• Coordinating with CFT for addressing & resolving Review Comments for timely Closure.
• Review & approval of, Trends, APQR, SOPs, Quality Risk Management (QRM), cleaning validation (CV), Method validation, protocols & reports
• Providing necessary support to the technology transfer projects
• Ensure microbiology policies, procedures conform to Pfizer
• Report any non-compliance to the Manager
• Experience in handling regulatory, corporate and internal auditors/ inspectors
• Supporting Continuous Improvement(CI) activities

How You Will Achieve It

• Contribute to the completion of projects, manage own time to meet agreed targets and develop plans for work activities on own projects within a team.
• Suggest improvements and conduct continuous improvement activities.
• Independently assess a wide range of Change Control activities to determine potential Quality and Operational Good Manufacturing Practices {also cGMP} impacts.
• Investigate, and document Quality Assurance related deviations and escalate issues as appropriate to the Quality Assurance Lead in a timely manner.
• Maintain regulatory compliance in accordance with current Good Manufacturing Practices {part of GxP} practices.
• Provide Quality Review and oversight of site cGXP documentation related to the operation of a vaccine manufacturing facility/laboratory to ensure compliance with global regulatory agencies and Pfizer quality standards.
• Accurately communicate Supply/Operational needs/perspectives as well as Quality Operations (QO) perspectives.
• Review and approval of validation documents Process, cleaning & method validation.
• Develop an annual product quality review plan.
• Review and approve master batch records and executed batch records to assure compliance with regulatory standards and regulatory filing.

Qualifications

Must-Have

• Bachelor’s Degree/Master’s Degree in Microbiology
• 6+ years’ experience
• Experience in Quality administered systems
• Knowledge of current Good Manufacturing Practices and the applicable GxP regulations and standards
• Proactive approach and strong critical thinking skills
• Must be able to work in a team environment within own team and interdepartmental teams
• Excellent communication and interpersonal skills
• Good working knowledge of Microsoft Excel and Word.

Nice-to-Have

• Master’s degree and relevant pharmaceutical experience
• Willing to lead by example and jump right in, desire to get to root cause, collaborative and active, listener.
• Effectively manages stressful situations, able to focus on the task regardless of circumstances and stress-induced pressure.

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