Asst Manager (Quality)

Educational Qualification

BE/BTECH Mechanical

Primary Responsibilities

• Review of APQR, audit response, all type of qualifications and validations, self-inspection, Change control, Deviations, CAPA, Incident report, OOS, VMP, SMF, customer complaint, Stability study, SOP’s, Training within timelines
• Ensure timely batch release. Responsible & authorized for release.
• Application for new additional Product, WHO Certificate, ISO, EXCiPACT certification, FDA Approval, Free Sale certificate. Liaison with various regulatory and accrediting bodies for obtaining the same.
• Handle Customer, Regulatory and internal audit (self-inspection at the plant, GQA audit). This includes planning, execution, implementation of CAPA and closure of the same.
• Ensure and drive the document (BMR, SOPs, Formats, etc.) control at the plant. This involves the system for issuance, traceability, up-dation, reconciliation, retrieval, archival is in place and review the same.
• Preparation of Master Formula of all products as per License.
• Ensure all the validation & qualification activities are implemented as per protocol and ensure execution of validation master plan.
• Lead the investigation of customer complaint and provide response on the same with the support of other stakeholders (QC/Other Plant departments etc.)
• Review deviations for RM, finished products and systems