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Senior Executive-QA

at Spektrum

Thane Full Time

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About this role

Be the First to Apply Job Description Senior Executive-QAJob Description Business: PPL Department: Quality Assurance Location: Navi Mumbai Travel: Low Job Overview As A Senior Executive – Quality Assurance is responsible for ensuring quality oversight and compliance of QC and manufacturing activities through thorough review of analytical data, batch records, and QMS elements. The role involves batch release management, review of electronic and manual QC data, and ensuring adherence to cGMP, data integrity, and regulatory requirements. The incumbent will also support cleaning validation, line clearance, dispatch activities, and preparation and review of Annual Product Reviews (APR) to ensure consistent product quality and regulatory compliance. Roles and Responsibility: •Review and evaluation of QC analytical data, including thorough electronic data and audit trail review to ensure data integrity. •Batch Release Management •Hands on analytical experience •Review of batch manufacturing and packaging records, including audit trail verification. •Preparation and Review of APR •Oversight and review of QC laboratory activities to ensure adherence to SOPs and quality standards •Initiation, investigation, and review of QMS elements such as Deviations, Change Controls, OOS, OOT, and CAPA •Verification of dispatch activities and line clearance to ensure compliance with GMP requirements. •Review and execution of cleaning validation activities in accordance with regulatory guidelines Preferred candidate profile: - Masters/bachelor’s degree in chemistry or a related field. - Basic understanding of peptide synthesis principles is a plus. - Strong attention to detail and commitment to quality. - Ability to work in a team-oriented environment. - Good communication and interpersonal skills. - Willingness to learn and adapt to new processes. Essential Qualification Masters/bachelor’s degree in chemistry or a related field.Full time

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