QA Assistant Manager Job Vacancy in Upman Placements Pvt Ltd Ahmedabad, Gujarat – Updated today
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Company Name : Upman Placements Pvt Ltd
Location : Ahmedabad, Gujarat
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Job Description : Co. Profile – Manufacture automated single-use perfusion bioreactor systems and provides custom services for GMP production from pre-clinical to commercial in mg to kg quantitiesLocation – Moraiya – Ahmedabad (Staff bus facility)Designation – QA Assistant ManagerExperience: 4-10 years experienceSalary: As Per Candidate (Company Budget 4.00 LPA to 7.00 LPA)Education: B.Sc/B.Tech. or M.Sc/M.Tech. in BiotechnologyTiming – 8.30 AM To 5.00 PM (Monday to Saturday)Job Profile · Strong knowledge and experience of working/implementing of ISO 9001, ISO 13485,· QA of design, manufacturing, distribution, and service· Understanding of product development lifecycles, design development & change, process verification and validation methodologies, manufacturing/production process control methodologies, and servicing in a medical device environment.· Perform internal and external audits (Self-inspections and supplier audits)· Preparation and implementation of internal policies and SOPs· Manage Change Control Requests, Non-Conformities, FMEA, CAPAs, deviations etc and ensure their adequate and timely closure.· Guide audit readiness of the entire facility (ISO 13485, FDA 21 CFR 820 etc)· Draft and finalization of APEX documents (Validation master file, Validation protocol & report, site master file, medical device/product master file, product validation/master report, APQR (annual product quality report), Quality policy, Quality Agreements etc)· Draft, review of Batch Manufacturing Records (BMR) & other technical reports· Providing internal and external (QMS) trainings· Performing regulatory gap analysis.· Validation of cleanroom· Guide new product development team to ensure quality and regulatory aspects.· Guide stakeholder departments (QA, QC, Manufacturing, Warehouse, Engineering, Admin etc) for adherence to producing a quality product.· Develop product documentation for regulatory submissions.· Lead or guide engineers to develop and improve the quality control through appropriate statistical tools (strategic sampling plan, SPC, capability study etc.)· Conduct failure analysis of returned/recalled product#medicaldevice#iso13485Job Types: Full-time, Regular / PermanentSalary: ₹40,000.00 – ₹65,000.00 per monthBenefits:Food allowanceLife insurancePaid sick timePaid time offProvident FundSchedule:Morning shiftExperience:QA in Medical device company: 4 years (Required)Speak with the employer+91-XXXXXXXXXXApplication Deadline: 10/03/2022
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