Manager / Dy Manager - QMS - BIo-Analytical
- Harvas Management
- 9 - 12 years
- Chennai
- 4 years ago
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Job Description
Roles and Responsibilities :
- Responsible for QMS Department
- Ensure the companys manufacturing operations are compliant with all relevant Medical Device Regulations.
- Liaising with External and Internal Customers to meet organizational Objectives.
- Establish various QA, QC & production related processes i.e Incoming / In-process & finished product testing and manufacturing process
- Investigate Resolve and Report non-conforming products both Internal and external.
- Create and update SOPs for overall Quality Control and Production department with effective implementation trainings.
- Coordinate with the supplier selection and evaluation and maintain the Quality agreements for all critical suppliers and monitoring their performance.
- Manage the supplier audit and Approval processes.
- Prepare Regulatory Documents based on ISO 13485:2016
- Conduct internal/ external audits and report non- conformance to the top management.
- Involve with ownership in Design and development, testing, and licensing of new products.
- Conduct stability study for all the existing & new products from scheduling to reporting.
- Maintain Control formats, records, and reports for Quality & Production department.
- Maintain training records for all the trainings & Re-trainings.
- Update quality control manual as necessary.
- Responsible for SAP approval for RM, in-process and Final Inspection.
- To prepare and review raw material specs/design/ drawing.
- Ensuring Calibration/ external testing are followed as per schedule and documented.
Desired Candidate Profile :
- BE / B.Tech Biotechnology or Biochemistry
- 9 - 12 years experience in Bio-Medical / Bio Analytical Instruments, Consumables or related manufacturing industries preferred.
- Thorough knowledge of QA/QC and Regulatory Document filing experience based on ISO 13485/2016 is highly essential.
- Age : 30 - 36 years
- Candidates living in and around Oragadam Industrial Corridor or who're willing to relocate nearby preferred.
Perks and Benefits
At part with Industry standards
Co. Transportation arranged
Canteen facility Available
Interested talents who meet the above requirements may forward CV to ad**n@ha***s.net and a copy to ra******n@ha***s.net
Regards,
Harvas Management Solutions Pvt Ltd.,
+91 98403 46894 | +91 96000 23400
Job Classification
Industry: BiotechnologyFunctional Area: Quality Assurance, Role Category: Production & ManufacturingRole: Production & ManufacturingEmployement Type: Full timeEducation
Under Graduation: B.Tech/B.E. in Bio-Chemistry/Bio-TechnologyPost Graduation: Post Graduation Not RequiredDoctorate: Doctorate Not RequiredContact Details:
Company: Harvas Management Solutions Pvt LtdLocation(s): Chennai
Keyskills: QA Quality Audit Biotechnology QC Quality Management System QA/QC RA QMS Quality Assurance Quality Control
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