Address
Form of work Description/Comment: DURATION - 12 MONTHS - REMOTE - SHIFT - M/F 8-5PM - EDUCATION - Bachelor's degree in Computer Science, Business Administration, other Science related field. EXPERIENCE - In lieu of Bachelor's degree a minimum of 5 years of Quality or IT role supporting Enterprise Systems and 7 years total relevant experience will be considered.
The Global Enterprise System Compliance team is responsible for implementing and sustaining a world class Quality Management System and ensuring that Catalent Pharma Solutions meets all customer and regulatory agency GMP/Regulatory requirements and expectations. The Catalent QMS establishes the requirements for how Catalent Pharma Solutions complies with all applicable regulations and guidance worldwide, including but not limited to, Good Manufacturing Practice/quality systems requirements of the US Food and Drug Administration, Canadian, European, South American, Asian (including Japanese and Chinese), Australian, and any other agencies where Catalent sites are based and other International and/or local health authorities.
The Quality Specialist, Global Enterprise Systems is responsible for supporting the infrastructure and processes for GMP/Regulatory compliance within Catalent Pharma Solutions, with particular emphasis on Quality oversight associated with Global Enterprise systems project support.
The role will provide advice, guidance, support and information to Catalent projects and functions on CSV compliance with Catalent global Quality policies and cGMP. This role will ensure up to date application of modern CSV and compliance requirements applicable to computerized systems supporting Catalent GMP operations.
The role will require the interface with Catalent facilities, business units and functions and the coordination of teams to enable collaboration and alignment to the CSV and Data Governance/Integrity requirements of the Catalent QMS
Oversee Computer System Validation (CSV) for Global Enterprise systems, including review and approval of central CSV documentation, to ensure compliance and adherence to CSV policies and standards.
Ensure that deployed systems comply with all applicable GxP, legal, and fiduciary policies, practices and requirements.
Assess changes to computer systems and data integrity regulatory requirements and communicate requirements to central functions and sites.
Review and approve global IT change controls.
Review and approve periodic reviews of central systems.
Collaborate on the maintenance of global CSU policies, standards and procedures.
Other duties as required in support of Catalent Pharma Solutions; mentoring other individuals within the organization in compliance; participating in assessments; facilitating and conducting training.
Key Competencies
Global IT Quality systems knowledge and knowledge of CSV regulations and requirements.
Familiarity with computer infrastructure, servers, workstations, operating systems.
Able to develop and foster a global presence by maintaining healthy relationships with the Quality team delegates at all sites in the network.
Ability to manage other personnel, whether they are in-house permanent, temporary associates or consultants.
Ability to effectively present information, respond to questions from peers, management, and suppliers.
Education or Equivalent Requirements:
Example: (Minimum education/experience required to perform job)
Bachelor's degree in Computer Science, Business Administration, other Science related field
In lieu of Bachelor's degree a minimum of 5 years of Quality or IT role supporting Enterprise Systems and 7 years total relevant experience will be considered.
Pharmaceutical and/or life sciences experience including Computer System Validation, 21 CFR Part 11 and general GxP experience preferred.
Strong interpersonal, communication and problem-solving skills. Hours: 8:00am to 5:00pm Location: 119 1300 S Patterson Dr 20-2000478 Bloomington IN 47403 United States Education: Additional Job Details:
The Global Enterprise System Compliance team is responsible for implementing and sustaining a world class Quality Management System and ensuring that Catalent Pharma Solutions meets all customer and regulatory agency GMP/Regulatory requirements and expectations. The Catalent QMS establishes the requirements for how Catalent Pharma Solutions complies with all applicable regulations and guidance worldwide, including but not limited to, Good Manufacturing Practice/quality systems requirements of the US Food and Drug Administration, Canadian, European, South American, Asian (including Japanese and Chinese), Australian, and any other agencies where Catalent sites are based and other International and/or local health authorities.
The Quality Specialist, Global Enterprise Systems is responsible for supporting the infrastructure and processes for GMP/Regulatory compliance within Catalent Pharma Solutions, with particular emphasis on Quality oversight associated with Global Enterprise systems project support.
The role will provide advice, guidance, support and information to Catalent projects and functions on CSV compliance with Catalent global Quality policies and cGMP. This role will ensure up to date application of modern CSV and compliance requirements applicable to computerized systems supporting Catalent GMP operations.
The role will require the interface with Catalent facilities, business units and functions and the coordination of teams to enable collaboration and alignment to the CSV and Data Governance/Integrity requirements of the Catalent QMS
Oversee Computer System Validation (CSV) for Global Enterprise systems, including review and approval of central CSV documentation, to ensure compliance and adherence to CSV policies and standards.
Ensure that deployed systems comply with all applicable GxP, legal, and fiduciary policies, practices and requirements.
Assess changes to computer systems and data integrity regulatory requirements and communicate requirements to central functions and sites.
Review and approve global IT change controls.
Review and approve periodic reviews of central systems.
Collaborate on the maintenance of global CSU policies, standards and procedures.
Other duties as required in support of Catalent Pharma Solutions; mentoring other individuals within the organization in compliance; participating in assessments; facilitating and conducting training.
Key Competencies
Global IT Quality systems knowledge and knowledge of CSV regulations and requirements.
Familiarity with computer infrastructure, servers, workstations, operating systems.
Able to develop and foster a global presence by maintaining healthy relationships with the Quality team delegates at all sites in the network.
Ability to manage other personnel, whether they are in-house permanent, temporary associates or consultants.
Ability to effectively present information, respond to questions from peers, management, and suppliers.
Education or Equivalent Requirements:
Example: (Minimum education/experience required to perform job)
Bachelor's degree in Computer Science, Business Administration, other Science related field
In lieu of Bachelor's degree a minimum of 5 years of Quality or IT role supporting Enterprise Systems and 7 years total relevant experience will be considered.
Pharmaceutical and/or life sciences experience including Computer System Validation, 21 CFR Part 11 and general GxP experience preferred.
Strong interpersonal, communication and problem-solving skills. Hours: 8:00am to 5:00pm Location: 119 1300 S Patterson Dr 20-2000478 Bloomington IN 47403 United States Education: Additional Job Details:
