Quality Assurance - Medical Equipment
Job Description:
| To establish quality management system across all functions of plant related to quality |
| To execute & control QMS on a routine basis. |
| To prepare & approve all GMP related documents and control issuance, review, retrieval & storage securely. |
| To approve vendors for RM\PM. |
| To prepare specification, MOA, BMR, BPR, and control as per SOP of SOP. |
| Responsible for protocol & report approval of validation activities |
| To effectively train staff for GMP. |
| To plan & carry out Holding time studies and decided on final packing and retest dates based on study. |
| To prepare & approve APQR. |
| To Handle , Deviations , Change controls & market Complaints as per SOP in a timely manner & investigate take CAPA and follow through on compliance & final approval. |
| To Maintain GMP in production, warehouse & QC area. |
| To approve finished products for sale. |
| To carry out internal/external audits. |
| To monitor audit agreement done with customers. |
| To monitor equipment cleaning procedures for product change over & contamination control. |
| Any other specific task assigned by management from time to time. |
Desired Profile / Criteria / Skills :
Key Skills :
Company Profile
Client is an orthopaedic implants manufacturers & suppliers company approved by FDA and ISO. We are leading manufacturer & supplier of trauma implants for the surgical treatment of bone fractures, abnormalities and diseases of the hands, arms, hips, pelvis, legs, ankles and feet. Client an orthopaedic implants manufacturer furnishes physicians worldwide with a comprehensive suite of products. Among them are intramedullary nails, cannulated screws, external fixation devices, plates and related instrumentation. Committed to improving surgical treatment and serving individual patient needs, --- --- invests heavily in research and development. Resulting innovations in materials and technologies help surgeons to choose the best solution for every patient and procedure
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