Executive Quality Assurance

2 weeks ago

Navi Mumbai, Maharashtra, India Yashraj Biotechnology Full time ₹ 2,50,000 - ₹ 7,50,000 per year

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

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