{"title":"Quality Assurance/Regulatory Affairs Manager Position"}

2 weeks ago

Navi Mumbai, Maharashtra, India Septodont Full time
{"description":"

Job Summary

We are seeking a highly skilled Quality Assurance/Regulatory Affairs Manager to join our team at Septodont. As a key member of our organization, you will be responsible for ensuring that our products comply with all regulatory standards and that quality systems are maintained and improved.

Responsibilities

  • Oversee Quality Management System (QMS), policies and standards to support proper and smooth execution of Quality related activities in meeting the specified standards and requirements, consistent with GMP.
  • Ensure risk management principles are implementing through the organization in all activities.
  • Establish company quality plan including quality policy (based on corporate QA policies and procedures) and continually improve it.
  • Ensure deviations/non-conforming products management and implement preventive measures and corrective actions.
  • Ensure Quality Management System complies as per Drugs and Cosmetics Act, Medical Device Rule 2017, MDD & Medical Device Regulations and is effectively established, maintained and efficient.
  • Ensure suppliers and customers qualification, maintain their approved status according to applicable procedures.
  • Oversee internal audits as well as vendor/supplier/customer audits as per GMP & ISO 13485 & ISO22716 & MDR requirements.
  • Manage change controls and authorize their implementation after assessment and approval from authorities/notified body/legal manufacturer.
  • Facilitate and manage inspection or audit from customer, notified body and regulatory authorities and their follow up actions.
  • Continuously review quality control processes, procedures, and capabilities in order to sustain the most cost-effective and efficient methods for meeting quality requirements and making recommendations for improvement as appropriate.
  • Manage and control all quality control activities in accordance with identified Quality Assurance standards, company procedures, client specifications and contract requirements.
  • Assist in the production of generic and project-specific method statements and risk assessments.
  • Handle all product complaints and taking proper corrective measure under root cause analysis.
  • Provide training to all employees related to ISO, MDR, GMP and Medical device regulations as per EU.
  • Ensure all regulatory compliances related to products and processes are met.
  • Ensure regulatory watch and quality standard watch applicable to QMS and QC test.
  • Ensure process validation, cleaning validation, equipment and utilities qualification and monitoring, revalidation program and calibration.
  • Ensure batch record review and approve batch disposition.
  • Handle in Process QA activities of manufacturing and packaging areas.
  • Conduct and document management review, follow and communicate KPIs as defined.
  • Approve and coordinate any returned products and disposal of returned products.
  • To follow and adhere the requirement as mention in the following standard ISO 13485, ISO 22716, cGMP, MDR-2017

Qualifications


• Minimum bachelor's degree in science or related field (BioMedical, Biochemistry, Pharmaceutical Science, Biotechnology etc.), or experience demonstrating equivalent required knowledge and competencies.


• Certification in a regulatory or quality discipline would be an asset (IGMPI)


• 5+ years in a quality assurance management role in Medical Device and leadership equivalent role;


• Effective communication and report writing skills;


• Good negotiating skills with customer-oriented attitude;


• Excellent analytical abilities to grasp the key points from complicated details;


• Good leadership qualities to lead projects to successful completion;


• Basic knowledge of applicable software to infer statistical data;


• Familiarity with the tools, concepts and methodologies of quality management;


• Knowledge of and experience with all regulatory requirements concerning class I, II and III devices including


• Knowledge of QSR/QMS to support ISO-13485, ISO22716, GMP, Medical Device Regulation (2017/745), compliance/processes, CE Marks and audits;


• Experience with lab work;


• Familiarity with manufacturing techniques, project management and formal continuous process improvement techniques (Lean Management).

"}

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