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04 Jun

Manager – QA/RA

By Admin

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Email: pmcplconsultant@gmail.com  | cv@pmcpl.com

 

About Client:  Healthcare Solutions.

______________________________________________________________________
Position: Manager – QA/RA
Department - Quality Assurance
Location: Taloja

Reporting to: Vice President – Quality Assurance

Criteria: B.Pharma with 10+ Years of experience in Quality Assurance
 

Job 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 a company quality plan including quality policy (based on corporate QA policies and procedures) and continually improve it.

  • Promote quality achievement and performance improvement throughout the organization and report performance of the QMS to upper management.

  • Ensure deviations/non-conforming products management and implement preventive measures and corrective actions. Evaluate and ensure CAPA effectiveness.

  • 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.

  • Manage change controls and authorize their implementation after assessment and approval from authorities/notified body/legal manufacturer.

  • Oversee internal audits as well as vendor/supplier/customer audits as per GMP & ISO 13485 & ISO22716 & MDR requirements.

  • Prepare and implement the project inspection strategy to cover all project phases from the QA/RA perspective.

  • 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 productsTo follow and adhere the requirement as mention in the following standard ISO 13485, ISO 22716, cGMP, MDR-2017 

 

Authorities

  • Lead and Manage QA responsibility & Local regulatory activities in coordination with the France team Consultant for regulatory function

  • Act as the local pharma covigilance person and ensure vigilance cases processing in collaboration with Global Vigilance Department.

  • Management representative for ISO implements, SEC meetings and CDSCO (Delhi-FDA)

  • Authority to assess products for correct disposition and to release raw, packaging and finished product.

  • Authority to strictly enforce Company’s quality policies and procedures applicable for the compliance.

  • Authority to prepare job descriptions and/or duties lists for quality/RA personnel, when and where appropriate.

  • Within budgetary guidelines, authority to purchase equipment, chemicals, consumables etc. required for QA/RA department.

To apply for this job, send your resume on pmcplconsultant@gmail.com