Computer Validation Specialist
CAPS®, the nation's largest network of outsourcing admixture pharmacies, has been delivering high-quality, same-day, admixture services and solutions to hospitals and outpatient facilities for more than 28 years. Along with the nation’s largest 503A sterile injectable outsourcing network, CAPS offers industry-leading batch compounding on a national scale through three 503B registered outsourcing facilities. With experience, capacity, and a passion for safety, CAPS is your 503B solution.CAPS is part of the B. Braun Group of Companies in the U.S.
Establish guidelines for computer system validation and oversee the computer and controls validation program for CAPS to ensure compliance with state and FDA requirements
Responsibilities: Essential Duties
- Author and implement corporate and local policies and procedures pertaining to computer system validation and change control.
- Define standards to ensure compliance with FDA requirements for computer system validation and 21 CFR Part 11 compliance.
- Author or review procedures and policies pertaining to computer system validation, system life cycle maintenance, IT policies and operations.
- Author or review validation documentation for specific computer systems, equipment/process control systems, and computer networks, to include validation plans, system requirements, design, and validation protocols/reports.
- Provide technical guidance and quality oversight to IT and pharmacy staffs and contractors involved in computer and control system validation.
- Provide guidance to B.Braun US and Global operations concerning computer system validation requirements and standards that can impact CAPS operation.
- Review regulatory rules and guidelines pertaining to computer systems and electronic data and determine their impact CAPS operations. Stay current with FDA requirements for these rules.
- Act as QA Lead in specific computer-related projects in CAPS, including quality, laboratory, and compounding systems.
- Provide risk assessment on product nonconformance and field performance issues
- Support the planning of validation activities and staffing requirements for computer system projects
- Interface with personnel both within and outside department, external contractors/consultants, customers and Government agencies.
Expertise: Knowledge & Skills
- Good working knowledge of Pharmaceutical (USP <797>, 21 CFR 210 & 211, and 503B) and Medical Device (21 CFR 820) Quality System Regulations
- Good working knowledge of USP, FDA/cGMP, ISO, and ICH requirements
- Risk Management and Hazard Analysis Techniques
- Excellent computer and PC skills including experience with MS Office, statistical, and database applications
- Ability to act effectively as a member of a team to resolve problems.
- Project Management experience, including project initiation, team development, and desired results on time, on scope, and on budget.
- Ability to investigate and analyze technical and regulatory issues.
- Effective verbal and written communication skills.
- Effective interpersonal skills.
Expertise: Qualifications - Experience/Training/Education/Etc
- BS degree in technical or scientific discipline and five or more years of experience in Computer System Validation and Computer System/Database Design/ Programming preferably in the pharmaceutical and or medical device industry.
- Hands-on Experience in computer system specification development and validation
- Experience with USP, cGMP’s, and FDA guidelines.
- Valid driver license required
- Able to travel approximately 25% per calendar year
- Advanced degree in related science
- Knowledge and experience in LANCE, CAPSlink, Electronic Batch Record, Analytical Software, LIMS, Electronic Document and Asset Management System, Spreadsheet Validation, Learning Management Software
While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to use hands to handle or feel and reach with hands and arms. The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up to 20 pounds.
Responsibilities: Other Duties:
The preceding functions have been provided as examples of the types of work performed by employees assigned to this position. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed in this description are representative of the knowledge, skill, and/or ability required. Management reserves the right to add, modify, change or rescind the work assignments of different positions due to reasonable accommodation or other reasons.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually moderate.
What We Offer B. Braun offers an excellent benefits package, which includes healthcare, a 401(k) plan, and tuition reimbursement. To learn more about B. Braun and our safety healthcare products or view a listing of our employment opportunities, please visit us on the internet at www.bbraunusa.com. Through its “Sharing Expertise®” initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services.
Equal Opportunity Employer Veterans/Disabled