Job description

Title: Senior Specialist, CSV

Reports to: Senior Manager, IT

Department: IT

Location: Indianapolis

Position Overview:

This position is responsible for computer system validation and data integrity for GMP systems, ensuring they are in alignment with cGMP expectations, internal SOPs and requirements. Provides auditing support for the Supplier Management department as it relates to CSV.

Major Position Activities & Responsibilities:

• Computer System Validation / Computer System Data Integrity for all systems that contain processors and or generate data including lab, manufacturing, and IT based systems utilized in the support of cGMP activities, including developing and executing qualification protocols.

• As the cGMP computer system validation / computer system data integrity expert, develop and maintain company policy and procedures related to computer system validation and computer system data integrity

• Develop training curricula and provide training for and enforcement of data integrity policy and procedures site wide. Provide ongoing coaching to ensure effected personnel understand CSV process and government regulatory guidelines in preparation for internal/external audits

• Advises from a cGMP perspective, the functional areas on strategies for the life cycle management of data residing within computer systems (i.e. collection, storage, maintenance, backup, recovery, archival, retirement)

• Perform (lead) cGMP gap assessments with the functional areas for current computer system validations against cGMP expectation and current industry expectations. From a cGMP validation perspective, advises applicable functional areas on computer system validation and remediation approaches for new and existing systems. This includes aid/develop 21 CFR part 11 assessments for new and upgraded systems and software

• Develop and execute system validation deliverables based on software/hardware configuration for enterprise systems

• Update application system User Requirements, Functional, and Design Specifications

• Review and perform approval of validation change controls, protocols and completed validation packages finalized by other functional areas

• Continually improve CSV and Computer Systems Data Integrity by investigating, developing and implementing permanent corrective and preventive actions for process/system failures. Coordinate investigations to determine root causes and actively participate to develop and propose changes to prevent reoccurrence of issues

• Maintain qualification of Quality Assurance auditor and assist the Supplier Quality department in the performance of audits of computer systems vendors and service providers when requested

Scope:

• No direct supervision responsibilities.

Background Qualifications:

• BS in Science or Computer Science or Information Technology

• Minimum 10 years relevant experience computer system validation in pharmaceutical/medical device industry

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• Leadership, negotiation and conflict management skills

• Strong knowledge of EU, FDA and cGMP regulations related to the pharmaceutical, biotechnology industry

• Auditing experience within regulated biotech/pharma industry; experience in auditing suppliers/contractors; Certified Quality Auditor (CQA) designation a plus

• Strong knowledge of EU, FDA and cGMP regulations related to the pharmaceutical, biotechnology industry

• Excellent interpersonal effectiveness and written communication skills

• Ability to travel up to 20% of the time (domestic and international)

• Ability to influence and work independently and in a team environment'

'Work Location: * One locationWork Remotely

• No

Job Type: Full-time

Pay: $80,000.00 - $115,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Employee discount
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Referral program
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday

Supplemental pay types:

• Bonus pay

Application Question(s):

• What are your salary requirements?

Education:

• Bachelor's (Preferred)

Work Location: One location

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