Executive Quality Assurance (QA)

Job Description

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