Johnson & Johnson Chemistry & Pharmacy Job - Apply Online

Chemistry & Pharmacy Job @ Johnson & Johnson – Apply Online

Johnson & Johnson hiring chemistry job opening 2022. Chemistry job opening 2022. MSc Chemistry job opening 2022. Pharmacy job opening 2022. Chemistry and pharmacy job opening 2022. Pharma job opening 2022. Johnson & Johnson job opening 2022. Check out all the details on the same below:

Job Title: Regulatory Compliance Specialist

Location: Aurangabad, India

Department: Quality

Id: 2206066682W

Elibgility Criteria:

  • Graduate/Postgraduate in Science (Organic, inorganic or physical chemistry), Pharmacy,
  • 8-10 years of relevant experience.
  • Detailed knowledge of medical device regulatory requirements is necessary
  • ISO 13485 Lead Auditor certification preferred
  • Experience in quality system auditing to both MDR-2017 ISO 13485 and ISO 9001 standards
  • Experience in change management and project management

Skills: 

  • Ability to use Microsoft office tool.
  • Ability to work effectively with cross-function teams.
  • Strong desire to commit, be held accountable and be rewarded for delivering results.
  • ISO 13485 Lead Auditor Certification will be an advantage

Technical Skills & Professional Competencies:

Operational Excellence-

  • Analytics & Problem Solving – Proficiency in analytics and problem-solving.
  • Technology & Data Management- Applies to understand of technology tool capabilities to execute job responsibilities
  • Decision Making- Builds skills to apply data-driven decision techniques
  • Knowledge Management- Applies the knowledge of J&J standards to ensure quality contributions

Quality & Compliance-

  • Quality Mindset- Applies knowledge of validation strategies and/or continuous improvement concepts to proactively identify process deficiencies or improvement
  • Compliance Orientation- Demonstrates ability to utilize various global databases according to compliance requirements
  • Environment Health & Safety- Demonstrates knowledge of concepts and policies related to the environment, health, and safety (EH&S)

Responsibilities: 

  • Responsible for establishing and maintaining a robust compliance program for the assigned Ethicon Aurangabad site in order to ensure compliance to local, national and international regulatory standards, company policies, procedures and J&J corporate requirements.
  • Conduct internal audits of the manufacturing site according to the approved Internal Audit Schedule
  • Prepare internal audit schedule as per SOP of internal audits.
  • Establish and maintain a regulatory inspection readiness plan at the Aurangabad site in preparation for any regulatory inspection (internal corporate or external audits). Support manufacturing site regulatory inspections as required
  • Collaborate with the Site functional teams to formulate responses to internal corporate or external audit observations, including identification and implementation of corrective and preventive actions. Ensure effective and timely completion of all remediation actions.
  • Gap assessment of current procedures against revised standards and regulations. Information to process owners on gaps identified and follow-up to review related procedures.
  • Maintain a list of qualified auditors at the site.
  • Provide training to qualified auditors and other staff on the revised audit procedures.
  • Provide training to new entrants on ISO 13485 standard, auditor training as applicable and other compliance-related trainings (Good Documentation Practices, Data Integrity, etc.)
  • Co-ordinate and support lead and team auditors for timely conductance of internal audits, report preparation, and distribution.

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