QA Validation Job Description
QA validation
provides validation support on product, process, equipment, software, and facilities changes while ensuring the validation and qualification activities are consistent with regulations and Cantel’s validation practices and procedures.
QA Validation Duties & Responsibilities
To write an effective QA validation job description, begin by listing detailed duties, responsibilities and expectations. We have included QA validation job description templates that you can modify and use.
Sample responsibilities for this position include:
Write, review, and approve validation master plans, validation plans, SOP’s and other validation documentation
Leads projects by developing appropriate plans, schedules, resource loading and other project deliverables as required Execution of validation projects and overseeing Validation projects junior-level staff
Coordinate with Validation (either in-direct reports or peers) to ensure that Validation activities are appropriately planned to coincide with the overall project implementation
Prepare and plan validation studies in support of ongoing validation
Validation impact assessment regarding changes to validated systems and processes
Generating, reviewing and/or approving validation documents (protocols, reports) and SOPs
Managing the execution of approved validation and qualification protocols, requiring product sampling and strong communication skills
Troubleshooting / investigating validation-related deviations
Assuring validation documentation is available for all operational activities
Maintaining organization and archival of completed validation and qualification document packages
QA Validation Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for QA Validation
List any licenses or certifications required by the position: CMQOE, CQE, HEPA, PV, PQ, OQ, IQ
Education for QA Validation
Typically a job would require a certain level of education.
Employers hiring for the QA validation job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Master's Degree in Engineering, Science, Technical, Chemistry, Biotechnology, Computer Science, Life Sciences, Sciences, Biology, Education
Skills for QA Validation
Desired skills for QA validation include:
Microsoft Suite
Validation
Good practices in biopharmaceuticals
Different regulations and standards related to validation activities
CGMPs for biotechnology
FileMakerPro
GMP Regulated environment related to validation activities
Kaye Validator
Microsoft Office Suite
Professional field and industry
Desired experience for QA validation includes:
Supporting all policies/procedures to regulatory agencies/customers
Building and maintaining a strong working relationship with all internal and external operational groups
Responsible for drafting, reviewing and approving commissioning and qualification documentation for new systems and equipment
The scope of responsibility encompasses the product life cycle for existing commercial pharmaceutical and biopharmaceutical products emerging products and platforms
Provide QA support for Laboratory method validation and equipment qualification
Work with Planning, Production, Engineering, Technical Services and QC Laboratory to establish priorities
QA Validation Examples
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QA Validation Job Description
Job Description Example
Our growing company is looking to fill the role of QA validation. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.
Responsibilities for QA validation
- Assist in the development and maintenance of the computer validation training programs and present training in regulatory requirements for validation, maintenance, and operation of computer technologies
- Review and approve validation reports in support of product release
- Proposes site-specific validation procedures and shared practices as applicable in accordance with the requirements set forth in the governing quality standards in partnership with corporate procedures
- Reviews and approves the validation approach and protocol results
- Provides technical input to validation deviations
- May prepares equipment for qualification studies and executes qualification and validation studies according to approved protocols and SOPs
- Prepare protocols for validation/qualification of existing processes/methods and equipment
- Assist in training Process Operators, QC analysts, and other staff in regards to validation procedures and protocols
- Coordinate the implementation and scheduling of validation testing with affected departments and personnel
- Write, review and approve validation deviations
Qualifications for QA validation
- Degree in in Pharmacy or Science or equivalent manufacturing within pharmaceutical and related industries
- Minimum of 6 to 7 years in relevant experience in Quality or
- Capable of managing and developing team to promote teamwork
- Accountable for ensuring cleaning, processes, equipment, and computer systems remain in a validated state
- Reviews and approves protocols to ensure they meet current regulatory requirements and industry practices
- Applies theory, technical principles, and judgment to address a broad range of difficult projects/problems
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QA Validation Job Description
Job Description Example
Our company is growing rapidly and is searching for experienced candidates for the position of QA validation. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for QA validation
- Perform validation assessments and testing as needed per approved changes and modifications to the plant
- Participate in capital projects as a design team member to ensure proper selection of new equipment in support of validation
- Understands validation/technical problems and evaluates their potential impact on product quality
- Provide quality assurance monitoring of projects to assure regulatory compliance of complex and critical computer systems at designated sites, assisting with the development and/or review of validation deliverables
- Assist with operational components, to develop and maintain an inventory of computerized systems used in regulated operations and their status relative to the Master Validation Plan (MVP)
- Review validation plans, test results, and summary reports for regulatory compliance
- Maintain an up-to-date knowledge of computer validation requirements, practices and procedures, and inform other company staff of those requirements
- Provide compliance guidance to operational personnel on regulatory requirements for computerized system validation, development of user requirements specifications, testing strategies, and documentation requirements
- Organizes QA Validation resource assigned to functional area to meet goals and timings
- Assist in development, implementation, and enforcement of computer validation policies and practices
Qualifications for QA validation
- Provides technical support and guidance to other project team members in protocol preparation/review, execution and data interpretation
- Reviews and interprets data for accuracy of completed validations/re-validations
- Successfully project manages project staff to ensure deliverables are met on time and within allocated budget
- Reviews and approves controlled documents relating to processes, cleaning, equipment, and computer systems in the manufacture of product
- Reviews and approves change requests, ensuring they will not lead to breach of GMPs
- Participates in inspection preparation activities
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QA Validation Job Description
Job Description Example
Our company is growing rapidly and is looking to fill the role of QA validation. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for QA validation
- Define the CSV approach for the validation of new implementations and revalidation after modifications to existing software to ensure that application remains in a validated state
- Collaborate with QA, IT, business stakeholders and vendors to ensure successful planning, execution and delivery of validation projects
- Support the technical support and knowledge to MPU/SPU’s to guarantee manufacturing and quality validation are designed and executed to deliver expected product quality, robust, sustainable operations
- Participates in discrepancy investigations
- Ensures discrepancies are thoroughly identified, defined and properly assessed
- Interacts with interdepartmental contacts on discrepancy assessment, resolution, and quality approval
- Ensures metrics are tracked and requested reporting is accurate and timely
- Assists or interacts with regulatory agencies as necessary
- Coordinate with users to map out requirements and specifications
- Potentially some coordination with Regulatory to determine appropriate qualification package inclusion, depending on filings and submissions
Qualifications for QA validation
- A Bachelors’ degree is required with a focus in Engineering, Physics and/or Chemistry preferred
- Working knowledge of GMP guidelines, ICH Q7, Q8, Q9, Q10 and other international regulatory requirements
- Ability to make independent sound decisions and independently manage priorities in alignment with department and site drivers
- Working knowledge of bulk manufacturing process
- Able to present and defend GMP documentation associated with quality practices
- Six plus (6+) years of related professional working experience in drug substance and drug product manufacturing facility
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QA Validation Job Description
Job Description Example
Our company is growing rapidly and is searching for experienced candidates for the position of QA validation. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for QA validation
- May prepare equipment for qualification studies and executes qualification and validation studies according to approved protocols and SOPs
- Responsible for all aspects of the Cleaning Validation programs onsite for a large scale Biopharmaceutical Drug Substance production facility
- Responsible for managing the review/approval of design and commissioning documentation, validation protocols, reports and support records to certify compliance with specifications and procedures
- Acts as Quality contact and primary Subject Matter Expert (SME) for Validation and Quality Risk Management
- Represents the Validation Program for Quality Assurance Department in customer / regulatory audits and responding to audit observations and corrective actions
- Manage of process and test method validation activities related to manufacturing site
- Maintain site Master Validation Plan
- Lead Validation Review Board meetings
- Assist in validation activities (process, test method) at supplier sites as required
- Liaise with Tech-ops and R&D departments on validation requirements for new and current products and processes
Qualifications for QA validation
- Experience in qualifying equipment, laboratory systems, and computerized systems
- Experience with protocol development and execution
- Familiarity with GAMP 5, process control systems, Enterprise Resource Planning (ERP) systems, Manufacturing Execution Systems (MES) is preferred
- Bachelors’ and/or Masters’ degree required with a focus in Engineering, Physics or Chemistry preferred
- Four (4) to six (6) years’ experience leading projects is required
- Solid knowledge of Good Manufacturing Practice and international regulations
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QA Validation Job Description
Job Description Example
Our company is hiring for a QA validation. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for QA validation
- Train and support other departments in preparation of validation input documents
- Own validation and quality manufacturing KPI’s
- Maintain Process Validation Master Plan to ensure compliance with regulatory requirements and current industry practices
- Provide oversight of process, cleaning, and shipping validation in support of product manufacturing for commercial manufacturing
- Participate and provide technical expertise for Validation and Emergent during FDA and other regulatory agency inspections
- Validation support in authoring or reviewing of various compliance documentation such as deviations, CAPAs, change controls, and technical study protocols
- All functions associated with recruitment and hiring process for EMOB Validation positions (full-time, part-time, temp, Limited Term)
- Determine methods and procedures on new assignments with oversight from manager
- Provide insight and individual contribution in obtaining and maintaining compliance with ICH Q7 guidance for active pharmaceutical ingredients
- Perform risk analysis for process
Qualifications for QA validation
- A minimum of eight (8) years of experience in the industry
- Eight plus (8+) years of related professional working experience in drug substance and drug product manufacturing facility
- Proven experience in validations to support a multi-product manufacturing facility
- Experience in process validations relevant to biopharmaceuticals is preferred
- Requires a BEng/BSc in Engineering, Chemistry, or Life Sciences with 6+ years of related experience within the field
- Bachelor’s degree in a scientific discipline or four (4) years of experience in lieu of degree