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22 days old

Computer System Validation / Quality Specialist

Kelly Services
Bloomington, IN 47407
Kelly Services is seeking a **Computer System Validation** for one of our leading clients.


*** If this position may be interested to you, please email me back at somp767@kellyservices.com (with your most up to date resume in word format) and advise the best time and number at which you can be reached ****


**Job Title:** **Computer System Validation / Quality Specialist**


**Location: REMOTE (Company location- Bloomington, IN)**


**Type: ONLY on W2 contract (NO C2C)**


**Length: 12 months**


**Pay Rate $92.85 per hour (Max rate)**


SHIFT - M/F 8-5PM


**EDUCATION**


Bachelors degree in Computer Science, Business Administration, other Science related field. EXPERIENCE


In lieu of Bachelors 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)


+ Bachelors degree in Computer Science, Business Administration, other Science related field

+ In lieu of Bachelors 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.


Soma Patanaik

IT Recruiter

_Email:_ _somp767@kellyservices.com_

Web kellyservices.com


Phone no- 425-866-6202


**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.


**Why Kelly** **** **?**


By partnering with Kelly Technology, youll have direct connections to top companies around the globegiving you the chance to put your tech skills to work on some of todays most intriguing, innovative, and high-visibility projects. In a world where change is the only constant, our unparalleled connections and IT market expertise help you take your skills exactly where you want to go. Were here to help you gain experience, keep learning, and move your career forward.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.
Posted: 2021-11-15 Expires: 2021-12-16

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Computer System Validation / Quality Specialist

Kelly Services
Bloomington, IN 47407

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