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Pfizer
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Associate Manager-Manufacturing Compliance

Associate Manager-Manufacturing Compliance

Pfizer

2 - 8 years

0 Lacs

andhra pradesh

Posted:1 day ago| Platform: Shine logo

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Skills Required

quality assurance quality control audit regulatory requirements technical writing communication presentation skills microsoft office microsoft project statistical software complaint handling interpersonal skills training statistical methods good manufacturing practices problemsolving

Work Mode

On-site

Job Type

Full Time

Job Description

As a Quality Assurance Specialist at Pfizer, you will play a crucial role in ensuring the delivery of safe and effective products to patients. Your focus on evaluating corrective and preventive actions, maintaining Quality Assurance Auditing policies, and participating in audits and inspections will directly impact patient care. Key Responsibilities: - Evaluate corrective and preventive action responses to audit findings for adequacy and timeliness. - Ensure Quality Assurance Auditing policies and procedures comply with Pfizer Quality standards and Regulatory requirements. - Prepare for and participate in Manufacturing and Supplier Quality Assessment Audits (MSQA) and BOHs Inspections to ensure successful outcomes. - Manage routine Customer Quality complaints for commercial Drug Products in the global complaints management system. - Assist the Quality Control lab Supervisor with technical issues and protocol execution. - Apply statistical methods to various Production/Quality related processes and communicate findings effectively. - Implement Good Manufacturing Practices regulations and company policies. - Conduct detailed audit testing in connection with the investigation of policy violations. - Review area documentation and perform trend analysis on data and standards. Qualifications Required: - High school diploma with 8+ years of experience, or associates degree with 6+ years of experience, or BA/BS with 2+ years of experience, or MBA/MS with any years of relevant experience. - Demonstrated skills in conducting and documenting quality investigations in pharmaceutical or medical device manufacturing processes. - Strong understanding of Quality System functions, manufacturing processes, validations, and statistical processes. - Ability to apply mathematical concepts, particularly statistics, to Quality Engineering tasks. - Excellent technical writing, communication, and presentation skills. - Proficiency in Microsoft Office, Microsoft Project, and Statistical Software. - Experience in audits and inspections. Additional Company Details: Pfizer is committed to being an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction. We look forward to welcoming individuals who are passionate about quality assurance and control to join our team and make a positive impact on patient care.,

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Pharmaceutical Manufacturing

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Associate Manager-Manufacturing Compliance