Executive Quality Assurance (QA)

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