Executive Quality Assurance (QA) Yashraj Biotechnology

1.0 - 3.0 years

3 - 5 Lacs

Navi Mumbai

Work from Office

Role & responsibilities Inspection - release/rejection of incoming material against approved specification. Rejection of material non conformance review, reporting in IMSxpress. Updation of critical incoming material list (incoming material specification) based. Allocation of catalogue number to finished products depending on customization/changes in product. Control of documents (QSP, SOP, formats, MFR, MQR) issuance, retrival, archival and updation in IMSxpress. Compiling of data for MIS as per schedule Allocation of batches as per customer purchase order over mail. Review of certificate of analysis for finished products. Daily IPQA of production and BMF as per the approved protocols and procedures and subsequent reporting. Issuance and handling of change control, non conformity, CAPA in IMSxpress Issuance and handling of Deviations Issuance and maintenance of BMR Handling, Recording and compilation of customer complaints Updation and maintenance of departmental risk register. Participating in product Validation. Review of packing order, checking of labels and Shipments to customers. Participating in Internal/external audit as per audit agenda and responsibility allotted. Preferred candidate profile Should have a Bachelors or Master's degree in pharmacy/biotechnology/Biochemistry or other relevant scientific discipline with 2/3 years experience in Quality Assurance. Knowledge of GMP standards, SOPs and quality management systems • Awareness of QMS as per ISO13485: 2016 and ISO 9001:2015 standards • Data collection and management • Customer service orientation • Excellent relationship management skills with the ability to engage, negotiate and manage key stakeholders and suppliers • Strong and confident negotiator with the ability to negotiate at all levels • Excellent communication, interpersonal and influencing skills • Results orientated with ability to plan and deliver against deadlines • Ability to add value, reduce costs and make improvements • Computer literate, especially Excel skills

Posted 1 week ago

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Quality Assurance Manager | medical device mfg. co | Navi Mumbai Seven Consultancy

10.0 - 15.0 years

10 - 15 Lacs

Navi Mumbai

Work from Office

Oversee the entire quality assurance process, from raw materials to finished goods, ensuring consistent quality & compliance, ensuring that products meet regulatory requirements & quality standards like ISO 13485, ISO 9001, 21 CFR 211 & 21 CFR 820 Required Candidate profile Bachelors in science 10-15 years' experience in quality in medical device/ pharma industry QMS implementation experience Must have regulatory audit exposure Like WHO/ USFDA & EU GMP

Posted 1 month ago

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