Associate Principal QA Specialist (CQV)
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Job Location:
Monthly Salary:
Posted on:
10 hours ago
Vacancies:
1 Vacancy
Job Summary
Description:
Supervisory Organization QA
Reports to position QA Manager (CQV)
Job Title Associate Principal QA Specialist (CQV)
Primary Location Slough
Role Purpose & Scope
Enable site operations performance by managing and supporting GMP issues through QMS processes site governance and senior QA Leadership. Provide oversight on day to day Quality Assurance activities in the areas of Validation / Technical Services in accordance with Lonza Corporate requirements standards and current regulatory requirements meeting USFDA European requirements and others as applicable for a multi-product GMP biotech contract manufacturing facility.
Key Responsibilities
To provide shoulder to shoulder review approval and support for the management of quality records e.g. Deviations CAPA Change Controls Investigations
To provide oversight over day to day Quality assurance activities in the areas of Technical Services and Validation in accordance with Lonza Corporate requirements standards and current regulatory requirements
Utilize knowledge of GMP and quality processes within the functional areas to: Manage and escalate Major and Critical compliance issues through the site QMS processes e.g. deviations and CAPAs
To actively identify suggest and participate in continuous improvement activities
Mentor and coach business partners in cGMP practices to maintain and develop a cGMP environment
Maintain and promote a state of audit readiness
Actively suggest initiate participate and contribute to PQS process improvements initiatives and projects
Provide QA SME support at departmental Local Quality Councils and project meetings
Provide shoulder to shoulder review approval and QA Technical support to key business partners for the management of quality records e.g. Deviations CAPA Change Controls Investigations
Provide coaching and training to other team members
Provide QA SME support at departmental Local Quality Councils and project meetings
Provide QA project support to complex projects
Performs other duties as assigned.
Required Skills & Competencies
Demonstrates an ability and desire to learn from experience
Treats errors as a learning opportunity
Is willing to take on new challenges
Takes steps to adapt thinking and behavior to support change
Seeks to understand the corporate strategy and how his/her business area contributes to the company s success
Understands the impact of his/her own actions on his/her business area
Uses knowledge of his/her business area to make accurate and timely decisions
Works as an active member of his/her team
Generously shares information and knowledge with others in the team
Demonstrates an openness to different perspectives by balancing listening and speaking
Treats all co-workers and customers professionally and with respect
Understands what internal and/or external customers need from him/her to deliver in his/her respective role
Demonstrates an openness to receiving customer feedback
Takes action to enhance customer satisfaction within the scope of his/her role
Consistently delivers goals while monitoring KPIs with supervisor
Demonstrates persistence and motivation to overcome obstacles and challenges
Ensures quality standards are maintained while delivering results
Plans prioritizes and organizes work to deliver on time
Takes responsibility for his/her safety and that of others
Takes responsibility for personal choices and behaviors
Seeks feedback and reflects on his/her development needs in order to continuously improve
Contributes to a positive work environment
Acts as a reliable and dependable member of the team
Excellent decision-making and problem solving skills.
Strong Quality mindset
Strong business and interpersonal skills and be a persuasive communicator in written oral and active listening to influence peers and colleagues.
Strong Continuous Improvement mindset
Excellent communication skills (verbal and written).
Ability to meet strict deadlines.
Excellent organizational and planning skills.
Education/Degree
Scientific
Work Experience Area -QA
Level- Advanced - 5-10 years
Other Requirements
IT literate Familiarity with database entries verbal and written communication skills risk based decision making PQS experience Conforms to general site quality responsibilities Conforms to safety responsibilities
Reports to position QA Manager (CQV)
Job Title Associate Principal QA Specialist (CQV)
Primary Location Slough
Role Purpose & Scope
Enable site operations performance by managing and supporting GMP issues through QMS processes site governance and senior QA Leadership. Provide oversight on day to day Quality Assurance activities in the areas of Validation / Technical Services in accordance with Lonza Corporate requirements standards and current regulatory requirements meeting USFDA European requirements and others as applicable for a multi-product GMP biotech contract manufacturing facility.
Key Responsibilities
To provide shoulder to shoulder review approval and support for the management of quality records e.g. Deviations CAPA Change Controls Investigations
To provide oversight over day to day Quality assurance activities in the areas of Technical Services and Validation in accordance with Lonza Corporate requirements standards and current regulatory requirements
Utilize knowledge of GMP and quality processes within the functional areas to: Manage and escalate Major and Critical compliance issues through the site QMS processes e.g. deviations and CAPAs
To actively identify suggest and participate in continuous improvement activities
Mentor and coach business partners in cGMP practices to maintain and develop a cGMP environment
Maintain and promote a state of audit readiness
Actively suggest initiate participate and contribute to PQS process improvements initiatives and projects
Provide QA SME support at departmental Local Quality Councils and project meetings
Provide shoulder to shoulder review approval and QA Technical support to key business partners for the management of quality records e.g. Deviations CAPA Change Controls Investigations
Provide coaching and training to other team members
Provide QA SME support at departmental Local Quality Councils and project meetings
Provide QA project support to complex projects
Performs other duties as assigned.
Required Skills & Competencies
Demonstrates an ability and desire to learn from experience
Treats errors as a learning opportunity
Is willing to take on new challenges
Takes steps to adapt thinking and behavior to support change
Seeks to understand the corporate strategy and how his/her business area contributes to the company s success
Understands the impact of his/her own actions on his/her business area
Uses knowledge of his/her business area to make accurate and timely decisions
Works as an active member of his/her team
Generously shares information and knowledge with others in the team
Demonstrates an openness to different perspectives by balancing listening and speaking
Treats all co-workers and customers professionally and with respect
Understands what internal and/or external customers need from him/her to deliver in his/her respective role
Demonstrates an openness to receiving customer feedback
Takes action to enhance customer satisfaction within the scope of his/her role
Consistently delivers goals while monitoring KPIs with supervisor
Demonstrates persistence and motivation to overcome obstacles and challenges
Ensures quality standards are maintained while delivering results
Plans prioritizes and organizes work to deliver on time
Takes responsibility for his/her safety and that of others
Takes responsibility for personal choices and behaviors
Seeks feedback and reflects on his/her development needs in order to continuously improve
Contributes to a positive work environment
Acts as a reliable and dependable member of the team
Excellent decision-making and problem solving skills.
Strong Quality mindset
Strong business and interpersonal skills and be a persuasive communicator in written oral and active listening to influence peers and colleagues.
Strong Continuous Improvement mindset
Excellent communication skills (verbal and written).
Ability to meet strict deadlines.
Excellent organizational and planning skills.
Education/Degree
Scientific
Work Experience Area -QA
Level- Advanced - 5-10 years
Other Requirements
IT literate Familiarity with database entries verbal and written communication skills risk based decision making PQS experience Conforms to general site quality responsibilities Conforms to safety responsibilities
Additional Details
- CH - FTE Replacement (External Contractor) Reason : N/A
- Will Contingent Worker allocate time to project task codes : No
- If yes please enter exact project codes for allocation. : n/a
- Will this position require driving : No
- Job Posting IR35 determination : Submit PAYE Only
