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Assistant Manager QA/QC

Assistant Manager QA/QC

91HR

5 - 9 years

0 Lacs

maharashtra

Posted:22 hours ago| Platform: Shine logo

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Skills Required

quality assurance sop analytical method validation equipment qualification stability protocol corrective actions training deviations change control capa internal audit quality documentation data analysis trend analysis recalls process method validation water system validation ahu qualification utilities qualification instrument qualification raw material specification packing material specification final product specification test method validation onsite audits quality systems implementation batch manufacturing record batch packing record inprocess quality assurance data integrity compliance product quality improvement product audits fda licensing export orders qa failed processes analysis revalidations

Work Mode

On-site

Job Type

Full Time

Job Description

As an Assistant Manager/Manager in the Quality Assurance department, your role will involve the following key responsibilities: - Review and approve Standard Operation Procedures (SOP's) for all departments, ensuring timely review and revision as per the revision date. - Review and approve various validation protocols and reports including analytical method validation, process method validation, water system validation, and equipment/instrument qualification. - Approve raw material, packing material, semi-finished product, and final product specifications and test methods for analysis. Also, approve artwork and shade cards for printed packing material. - Review and approve stability protocols and data, ensuring product quality and compliance. - Coordinate and support on-site audits conducted by customers and agencies, evaluate audit findings, and implement corrective actions based on audit feedback. - Develop, prepare, and implement quality systems across the site, including conducting training for all staff. - Manage deviations, change control, CAPA, and batch manufacturing and packing record reviews and approvals. - Plan and execute internal audits for all departments to ensure data integrity compliance. - Maintain and improve product quality through audits, investigations of complaints, and preparation of FDA Licensing documents and QA Documents for export orders. - Prepare quality documentation and reports by collecting, analyzing, and summarizing information and trends related to failed processes, stability studies, recalls, corrective actions, and re-validations. - Undertake any additional responsibilities assigned by higher management as needed. Please note that this summary is based on the details provided in the job description.,

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Assistant Manager QA/QC