Sr. Executive /AM-Quality Assurance (For Supplier and Customer qualifications )

Job Description

ResponsibilitiesSupplier Qualification: Manage the initial qualification and periodic requalification of GxP and Non-GxP suppliers based on their scope of activities. Review and analyze the scope of supplier activities from commercial agreements, marketing authorization dossiers, and other relevant documents to determine supplier categorization. Coordinate communication with suppliers to request completed qualification documents and supporting information as per company requirements. Review supplier-provided documents for accuracy and regulatory compliance; provide feedback and request updates where necessary. Conduct independent verification of supplier licenses and relevant regulatory certifications to ensure supplier competency. Manage translations of non-English supplier documents via approved translation agencies. Maintain and manage the supplier management module/system, including creating and updating supplier records, coordinating with internal stakeholders, and resolving queries. Collaborate with internal stakeholders across functions to identify and qualify new suppliers for both GxP and Non-GxP purposes.Customer Qualification: Conduct initial qualification and periodic requalification of customers in line with internal quality systems. Coordinate communication with customers to request and obtain qualification documents and ensure compliance with regulatory and GxP standards. Review and verify customer-provided documents, including licenses and certifications, to ensure alignment with the requirements of their respective territories. Conduct independent verification of customer certifications and licenses for compliance with regulatory guidelines. Manage translations of non-English customer documents through approved translation agencies. Facilitate internal communication with relevant departments for customer qualification and approval, addressing any queries or concerns.Audit & Qualification Questionnaire Management: Record, track, and complete audit/qualification questionnaires received from suppliers or customers for external audits. Arrange for the collection of supporting documents requested by external parties as part of their audit process. Communicate and coordinate with internal and external stakeholders to ensure timely completion of audit questionnaires.Risk Assessments for Nitrosamine, Elemental Impurities, and Excipients: Conduct comprehensive risk assessments for nitrosamine impurities in drug substances, drug products, and packaging materials. Implement mitigation strategies for minimizing nitrosamine risks as per guidelines from global regulatory authorities (EMA, MHRA, ICH M7). Perform risk assessments for elemental impurities (per ICH Q3D) across the product lifecycle, evaluating manufacturing processes and raw materials for potential contamination. Collaborate with cross-functional teams to ensure data collection and ensure regulatory compliance. Lead excipient risk assessments, evaluating their properties, compatibility with APIs, and compliance with current safety standards. Monitor regulatory updates (e.g., ICH, EMA, MHRA) and ensure timely adaptation of risk assessments and risk control strategies. Prepare and maintain detailed documentation for all risk assessments, and support regulatory submissions with required data and reports.Education: Bachelors or Masters degree in Pharmacy, Chemistry, Pharmaceutical Sciences, or a related discipline. Experience: 5-8 years of experience in supplier and customer qualification, and/or risk assessments in a pharmaceutical environment. Expertise in regulatory guidelines such as ICH Q3D (Elemental Impurities), ICH M7 (Nitrosamines), and other international standards. Proven ability to manage external supplier and customer relationships and audits.Location: Vadodara (From Office Only),

Keyskills :
Regulatory GuidelinesSupplier QualificationCustomer QualificationAuditQualification Questionnaire ManagementRisk Assessments