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Quality Specialist (Compliance)

5.00 to 6.00 Years   Bangalore   04 Jul, 2020
West Pharmaceutical Services
Job LocationBangalore
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaGeneral / Other Software
EmploymentTypeFull-time

Job Description

Requirements:

  • Must have a third level qualification in Engineering/Quality/Science.
  • Level 8 qualification in a technical or related field plus 5 years of demonstrated experience in the administration of Quality Systems, or a combination of education and experience.
  • Must have 5+ years work experience in Medical Device or Pharmaceutical Manufacturing Environment.
  • A thorough working knowledge of quality systems such as ISO 13485 / 21 CFR Part 820 / 21 CFR Part 4/ EU GMP is essential. Knowledge of 21 CFR Part 210 / 211 would be considered an advantage.
  • Knowledge of and experience in setting up and maintaining an effective QMS.
  • Accredited lead auditor against recognised quality standards in support of internal and supplier audits
  • Have experience in the facilitation of quality risk management coupled with a good working knowledge of ISO14971.
  • Experience of hosting regulatory audits from either the European or US authorities
  • Must have excellent communication and written skills
  • Must be able to work in a fast paced environment.
  • Must be able to travel as required by the position.
  • Must be able to organize and prioritize tasks; must be detail orientated and self-motivated.
  • An ability to collaborate across functional lines and work effectively in a team environment
  • Must be able to work independently on own projects while working concurrently with all departments
Essential Duties and Responsibilities:
  • Understand and ensure compliance with internal procedures and external global regulatory requirements.
  • Lead investigations related to Quality System related issues to ensure a thorough root cause, containment / corrective and preventive action is implemented.
  • Support trend analysis and issuance of key reports to relevant departments.
  • Support responses to Competent Authority queries.
  • Support risk management, risk analysis and hazard analysis associated with complaint/post-market information.
  • Actively participate as Lead Auditor in Internal & External Audit Schedule.
  • Support of third party audits, control room set-up and management of general audit readiness throughout the business.
  • Post Audit follow-up and reporting both internally & externally on action completion and verification of effectiveness to ensure audit findings are closed out satisfactory.
  • DHR review of Medical Device to be conducted within the QMS.
  • Responsible for the scheduling, data collection and co-presenting Management Review.
  • Support and drive the improvement and culture for data integrity.
  • Coach and drive a culture of compliance and continuous improvement.
  • Develop processes and systems in line with best industry practice.
  • Coordinate the monthly Quality Systems KPI reporting activity both internally and to corporate level.
  • Support regulatory submissions as required.
  • Interface with other departments on a regular basis to ensure adherence to West QMS, drive quality improvements and compile/relay trends and occurrences throughout the year.
  • Act in accordance with the company s Guiding Principles and adherence to the corporate Code of Conduct.
  • Compliance to all site Environmental, Health and Safety requirements, training and regulations.
  • Compliance to all local site company policies, procedures and corporate policies.
  • Perform additional duties at the request of the direct supervisor.
Delegation of Duties: When absent from the site duties and responsibilities will be delegated to the following designatesJob Title: Quality Specialist Complaints and/or Quality Systems Co-ordinator(for Routine Quality System responsibilities)Job Title: Quality Compliance Manager & Quality Manager(for all responsibilities outside of routine Quality System responsibilities),

Keyskills :
coachingquality21 cfrbasispart 820iso 13485auditingquality assurancecontinuous improvement facilitationpolymerase chain reaction pcrcorrective preventive actionquality management systems

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