Computer Systems Validation and Compliance Director
Aztec Consulting
6d ago
source : Shine

Responsibilities :

Create and oversee a validation / compliance group to provide consulting services to Aztec clients.

Build validation and compliance group by hiring appropriate resources

Train resources to provide optimum level of compliance and validation services to Aztec clients

Manage and motivate validation and compliance group members

Conduct periodic audits of internal Aztec policies and procedures to ensure that projects are following internal compliance and validation procedures

Create and oversee data integrity policies for manufacturing, laboratory and enterprise systems to comply with regulatory guidance s and requirements (e.g., 21 CFR Part 11).

Create, review and / or approve Good Manufacturing Practice (GMP) documentation such as Standard Operating Procedures (SOPs), validation plans, user requirements specifications (URS), functional and design specifications (FS and DS), testing protocols (IQ / OQ / PQ), user acceptance testing, traceability matrices, validation reports, and change control documentation to support all validation activities per the validation master plan.

Perform and / or oversee all aspects of CSV including planning and developing validation strategies in conjunction with the customer and system owner(s), creating all required GMP documentation, and the actual validation(s) in conjunction with system owner(s) per the validation master plan.

Provide guidance and support to customer Quality Assurance (QA) and IT departments, and the system owner(s) with focus on both new and on-

going validation and compliance initiatives.

Stay up-to-date with industry best practices, industry benchmarks and FDA s views in regards to CSV.

Participate in internal and external audits, including Food and Drug Administration (FDA) Audits.

Assist with estimates of man-hours required to complete projects.

Manage execution of compliance and validation projects

Monitor progress of projects. Qualifications :

A Bachelors degree in Engineering or Science.

A minimum of eight (8) years experience in the Life Science industry.

8 years minimum experience in either an IT or Quality role performing and developing CSV processes and procedures.

3 years of experience managing a compliance / validation group

Extensive knowledge of CSV, GAMP 5, Data Integrity and 21 CFR Part 11

Practical application of CSV Industry Standard Best Practices Hardware & Software :

Experience validating and enforcing compliance with following types of systems is required :

Process Control Systems

Building Management Systems

Data Historians

Databases and Data Warehouses

ERP Systems

Other enterprise systems such as CMMS, etc

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