QA Compliance Job Description
QA Compliance Duties & Responsibilities
To write an effective QA compliance job description, begin by listing detailed duties, responsibilities and expectations. We have included QA compliance job description templates that you can modify and use.
Sample responsibilities for this position include:
QA Compliance Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for QA Compliance
List any licenses or certifications required by the position: ASQ, ISO, CFE, CAMS, CQA, CQE, CQM, RAPS, RQAP-GLP, APMP
Education for QA Compliance
Typically a job would require a certain level of education.
Employers hiring for the QA compliance job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Master's Degree in Science, Engineering, Education, Chemistry, Technical, Pharmacy, Biology, Microbiology, Life Sciences, Management
Skills for QA Compliance
Desired skills for QA compliance include:
Desired experience for QA compliance includes:
QA Compliance Examples
QA Compliance Job Description
- Establish and administers a process for receiving, documenting, tracking, investigating, and taking action on all complaints concerning the practice/organization’s compliance policies and procedures in coordination and collaboration with other similar functions and, when necessary, legal counsel
- Initiate, facilitates and promotes activities to foster compliance awareness within the organization and related entities
- Apply LEAN and Continuous Improvement methodologies to compliance processes, tooling and workflows
- Prepares monthly compliance metrics related to Internal Audits for Management Review and Plant Review
- Establish internal audit plans and execute such plans and follow-ups thus meeting all Novartis internal regulatory requirements to ensure compliance to quality systems on site
- Promptly escalate all compliance issues to Quality and Sr
- Provide tracking and trending for all supply chain and materials management compliance activities NOEs, EOE’s, CAPA’s
- Lead and be responsible for Quality Assurance for all cGMP activities overseen by TBU at Contract manufacturing and contract testing laboratories globally
- Leads efforts at the sites and influences the regional and global Quality organization to create policy, provide guidance and influence senior Leaders in the area of GMP compliance
- Provides the necessary leadership to create a vision, mission and road map for creating a culture of Quality and Compliance that is well integrated and supportive of end-to-end supply
- Maintain expert-level knowledge pertaining to the applicable area of specialization, such as Sony/Microsoft/Nintendo technical requirements, or online gaming infrastructure and technology implementation, ensuring that any changes are widely communicated and reflected in the testing process
- Provide ongoing support for local and/or remote testing teams in order to aid knowledge transfer and maintain sufficient skill-levels amongst all testing teams
- Set and manage the daily testing tasks for a small team of testers on the assigned project
- Identify best practice to ensure that effective and consistent testing methodologies are applied across different projects
- Aid in the development of onboarding and training materials for new testing staff
- Actively support development and embedded QA teams to aid them in designing and engineering products that meet prescribed and/or pre-agreed standards and requirements
QA Compliance Job Description
- Leads, coaches, mentors and develops a team of Quality and Compliance professionals
- Implement and manage systems for Quality Management, Quality Assurance, Data stewardship, and governance
- Conduct impact analysis for any project design changes with regular and frequent communication to partner teams
- Formulate strong relationships, based on skills, knowledge and trust, with development teams, embedded QA teams and other remote test teams
- Actively participate in global Specialized QA initiatives in order to drive greater collaboration and standardization between all regional Specialized QA teams
- Work with the QA console test team to define and execute on a vision around agile testing methodologies and progressive QA best practices to ensure high quality deployments in suitable timeframes
- Define, standardize and apply the QA strategy for product teams while remaining flexible to individual team needs
- Build strong relationships with business and technology members to understand the needs for the QA department and tools
- Assure timely completion of testing for projects comprehensive bug tracking and reporting
- Identify a strategy for maintaining consistent QA environments providing as much up time for testing as possible
- Demonstrable expert-level knowledge of software development processes and technical understanding of game elements
- Proven track record of leading a testing team within a QA organization covering platforms of a specific project
- Proven experience of successfully working within a distributed multi-site environment
- Strong knowledge of software development processes and technical understanding of game elements
- Ability to work as part of a team or as an individual
- Minimum 10 years’ experience in the Apparel or Home industry
QA Compliance Job Description
- Liaise with various internal R&D functions and external groups including vendors and contract auditors to ensure a high level of quality and consistency across the studies
- Active engagement with clinical teams and activities for assigned programs, and
- Assume difficult study or issue assignments
- Maintain expert-level technical knowledge pertaining to one platform or governing body, ensuring that any changes are widely communicated and reflected in the testing process
- Assist in prioritising work accordingly within the project schedule and ensure compliancy with all defined QA process
- Assist with verification of product designs and planned feature implementation in order to identify risks and issues in relation to the area of specialisation
- Formulate strong relationships, based on skills, knowledge and trust, with development teams, Dev QA teams and other remote test teams
- Support senior QA staff in producing testing reports, analysis, and process documentation as required
- Uses pallet jack and lift trucks to retrieve stored received merchandise from pallet racks for shipping
- Utilizes hand-held computers to process and audit the accuracy of the inventory levels
- Must be very organized and able to multi-task
- Must be self-motivated and able to motivate staff
- Strong knowledge of testing methodologies, software development processes and technical understanding of game elements
- Experience with QA tools for test automation and performance testing JMeter
- Agile or Waterfall experience a plus
- Ability to find solutions that do not follow a conventional QA approaches
QA Compliance Job Description
- Ensure audit readiness for pharmaceutical compliance to regulatory and client inspections
- Performs various computerized, lift truck, and manual tasks associated with the maintaining accurate inventory levels
- Manage all QA functions for all divisions and regions
- Establish quality metrics for key performance indicators
- Provide leadership and establish action plan for systematic management review of metrics, trends and corrective actions
- Maintain and update an active vendor manual
- Evaluate current vendors and potential new vendors in the areas of productivity capacity and performance
- Carryout risk analysis of vendors and formulate action plans where needed
- Additional responsibilities as required by department heads and executives
- Assist in the identification, implementation and maintenance of the program/organization’s policies and procedures in coordination with his/her immediate supervisor
- Demonstrate unwavering ethics and respect for all customers
- Proven track record of successfully working within a QA organization delivering multiple simultaneous projects
- Proven experience of successfully working within a distributed multi-site environment would be advantageous
- Good knowledge of software development processes and technical understanding of game elements
- Demonstrable experience in working with databases and workflow tools to manage tasks and report results
- Experience in research laboratory environment preferred
QA Compliance Job Description
- Act as the primary backup to the QA Pharma Compliance Lead
- Assist with the creation and communication of new and changing procedures to the site under the established documentation control procedures and in compliance with certification standards and company guidelines
- Perform internal audits for the maintenance and continuous improvement of the management system and compliance to regulatory requirements
- Review and release of batch records (both production and QC) in compliance with various internal and external requirements
- Oversee, direct, deliver, or ensure delivery of training and orientation to all employees, volunteers, medical and professional staff and applicable business associates
- Audit and monitor all regulatory-related plans throughout the practice/ organization’s network to ensure alignment between security, Q&R and privacy practices, and prepare reports for senior management and stakeholders
- Create and maintain internal auditing schedule and lead internal audits
- Conduct internal auditor training
- Manage CAPA system, participates in CAPA Board
- Participate in audits by Corporate and outside regulatory agencies
- Prepare Management Review reports
- Summarize CAPA and audit results for functional and Corporate management
- Certification in auditing is required
- Provides quality oversight and support to drug product and drug substance contract manufacturing operations in the following key areas
- Responsible for clinical batch disposition
- Bachelor of Science degree in a scientific discipline is required