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    Senior Executive-Qa

    Piramal Pharma
    6-10 years
    Not Disclosed
    Mumbai
    10 Jan. 8, 2025
    Job Description
    Job Type: Full Time Education: M.Sc Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Job Title: Senior Executive - QA

    Location: Navi Mumbai, Maharashtra, India

    Job Overview

    The Senior Executive - QA will be responsible for ensuring the quality of peptide products and compliance with regulatory standards through various quality assurance activities. The role involves reviewing batch manufacturing records, executing process performance qualification (PPQ), and supporting quality management systems (QMS) in a peptide manufacturing environment.

    Key Responsibilities

    Quality Management and Documentation

    • Review Batch Manufacturing Records to ensure compliance with GMP standards.
    • Execute and monitor Process Performance Qualification (PPQ) activities for continuous improvement.
    • Prepare cleaning validation protocols and monitor cleaning validation/verification activities.
    • Review SOPs, validation, and qualification records for accuracy and compliance.
    • Perform dispatch and line clearance activities to ensure proper documentation.
    • Prepare and maintain Annual Product Review documentation.

    Quality Systems and Compliance

    • Initiate and manage various QMS elements, such as change control, deviation management, and CAPA.
    • Investigate customer complaints, returns, and recalls, ensuring proper resolution.
    • Review reprocessing and reworking activities to ensure compliance with regulatory guidelines.

    Team and Stakeholder Collaboration

    • Work closely with the QA team and other departments in the plant to ensure smooth operations.
    • Coordinate with relevant departments to address any quality-related issues promptly.

    Qualifications

    • Educational Requirements: M.Sc. in Chemistry.
    • Experience: 6-10 years of experience in Quality Assurance, with knowledge and experience in peptide quality control.
    • Skills and Competencies:
      • Punctual, dedicated, and reliable with a proven track record.
      • Strong team player, with the ability to work independently when required.
      • Fluent in both written and spoken English.
      • Expertise in peptide quality assurance and quality management systems.
      • Strong attention to detail and problem-solving skills.

    About Us

    Piramal Group is a global leader in pharmaceutical and healthcare solutions, driven by ethical practices and a focus on inclusive growth. Over three decades, the company has expanded organically and inorganically to deliver high-quality products and services.

    Equal Employment Opportunity

    Piramal Group is an Equal Employment Opportunity and Affirmative Action employer. We provide equal opportunities for all applicants regardless of race, ethnicity, gender, disability, or other legally protected characteristics. Employment decisions are based on merit and qualifications, and we support accommodations for individuals with disabilities.

    About the Team

    Piramal Pharma Solutions (PPS) is a Contract Development and Manufacturing Organization (CDMO) offering comprehensive development and manufacturing solutions. With a global network, PPS serves customers with services ranging from drug discovery to commercial supply of APIs and dosage forms, specializing in peptide products and biologics.

    Join Piramal Pharma Solutions as a Senior Executive - QA and contribute to ensuring the highest quality standards for peptide products, supporting the company’s commitment to excellence in the pharmaceutical industry.

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