Datt Mediproducts Pvt. Ltd. is one of the top surgical and advanced woundcare companies in India and has emerged as a global organisation.
Post : Quality Assurance(Assistant Manager)
Job Responsibilities & Required Skills
• Effective monitoring and maintenance of Quality Management System as per ISO 13485.
• Supporting introduction of new product & processes by effective process validation
• Incoming Inspection of components and on time release to production.
• Ensure that the adequate Process Control in place and on time Production Batch release.
• Calibration of Instruments and Qualification of equipments.
• Support Complaint Handling Activities.
• Assists in internal audits, as a means of evaluating the effectiveness of the established Quality Systems and Good Manufacturing Practices.
• Ensuring that Change Control process is followed for all material, process & product related changes.
• Ensure the product quality and process capability through Statistical Quality Control (SQC) and Statistical Process Control (SPC).
• Clean Room maintenance and controls at par with worldwide standards.
Skill required:
• Experience with QA/QC activities of collagen materials – Combination products, Drug device combination, and Advance wound care.
• Exposure to EU GMP quality system and having exposure to USFDA inspection/audits is mandatory.
• Knowledge in handling Medical Device of all classes as per EMEA and USFDA.
• Mandatory experience worked in Clean room Class 10,000, 1000, 100.
• To study and understand the various procedures of Medical Device testing, Quality Control techniques, FTA, FMEA
• Expertise in the Testing and finished product release procedure.
• Very good in documentation practices making SOPs, Developing In-house Testing Techniques.
• Excellent record keeping and computer skills especially well-versed with Microsoft office.
• Basic understanding of physico-chemical testing, biological testing for full characterization, Clinical comparability pathway, develop investigational medical product.
Additional Information:
Experience- 2-4Yrs
Salary- Salary will not be constraint for the right Candidate.
Desirable Qualification: M. Pharma, / M.Sc. Biological Science or Biotechnology, Microbiology/ Molecular biology/Chemistry or equivalent, B.Tech/M.Tech
Job Location-Sohna(Gurgaon) Haryana
Interested candidate can share their CV with email ID- admin@dattmedi.com
Posted by
Ilyas Ashraf
Datt Mediproducts Pvt. Ltd.
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