Global 3rd Party QA Specialist
Apply NowCompany: Ceva Santé Animale
Location: Lenexa, KS 66215
Description:
Global 3rd Party QA Specialist
The success of a company depends on the passionate people we partner with.
Together, let's share our talents.
As a global leader in animal health, Ceva Animal Health believes our success is linked to our passionate people researching, developing , producing and supplying innovative health solutions for all animals, which contributes to the future of our diverse planet.
We are committed to ensuring the highest possible level of care and well-being for farm animals (poultry, pigs, ruminants), companion animals (dogs and cats) and wildlife.
Indeed, Our "Together, Beyond Animal Health" vision emphasizes that the health and wellbeing of people, animals and our planet are totally interlinked. More than ever, Ceva is committed to a "One Health" approach.
As part of our "Diversity, Equity and Inclusion" policy, Ceva Animal Heath is committed to the employment of people with disabilities and will make reasonable accommodations throughout the interview process to ensure an inclusive and accessible experience for all applicants. To request an accommodation, please contact a member of the Ceva Talent Acquisition team.
Yourmissions :
Location: Lenexa, KS
Job Summary and Purpose:
This position will oversee and manage Quality Assurance and Product Compliance in accordance with the applicable regulatory requirements (e.g. GMP's for US FDA, Canada, EU, and US-EPA) and Ceva corporate guidelines. The successful candidate must possess a high level of experience and knowledge of pharmaceutical industry regulatory guidelines and ability to interact effectively with contract manufacturer's (CMO's) and product distribution organizations. The 3rd Parties QA Specialist will assess the risk to Ceva regarding quality matters and communicate the potential risks to Ceva upper management.
Responsibilities and Key Duties:
Quality Assurance through Audits and Investigation
Perform external audits for Ceva activities ensuring the preparation of complete, concise and timely investigated reports
Ensure CAPA, change control activities are followed-up and closed out properly
Perform qualifying and oversight audits of CMOs who manufacture, package, and test EPA, FDA veterinary pharmaceutical products or products with other applicable regulations or guidelines
Develop and manage a system to ensure all quality investigations and audit deficiencies are properly abated
Receive CMO related complaints, evaluating them as product quality defects, supply chain
Responsible for investigations with CMO into product diversion and related issues
Document Management
Under limited supervision, implement and administer a Standard Operating Procedures ("SOP") program aligned to proper regulatory and business practice requirements
Write and/or edit SOPs pertaining to the Quality Assurance responsibilities and duties
Ensure consistency and appropriate storage of documents
Provide Quality Oversight of Ceva Contractors
Write Quality Agreements for CMOs. Review and approve critical GMP documents from the CMO (e.g. MBR, specifications)
Receive notification of Quality Issues from contractors; assess the risk to Ceva, communicate risk factors to Ceva management. Develop appropriate risk management strategies
Work with contractors to investigate Quality issues, assess root cause and develop effective CAPA; plan and coordinate annual quality meetings with critical contractors
Develop Key Quality Performance Indicators for Ceva contractors; define with contractors metrics on their KPIs and communicate them to Ceva Management
Review product annual reports and investigational information for regulatory compliance and quality risk
Provide regulatory guidance and expertise
Core Competencies:
Shape solutions out of complexity - Is open and curious of other perspectives
Client focus - Has in mind client's satisfaction
Collaborate with empathy - Has a positive attitude towards collaboration
Engage and develop - Clarifies short-term directions
Drive ambition and accountability - Proactively manages own and others work
Influence others - Communicates effectively
Technical / Functional Competencies:
Ability to maintain a professional demeanor even when confronted with stressful and/or potentially adversarial situations
Demonstrated ability to effectively interact with multiple cross functional teams (IT, HR, Regulatory, Customer Services, Sales, Legal, Field Sales, vendors, etc.)
Must be capable of simultaneously handling multiple tasks and project deadlines
Demonstrated flexibility, willingness to take on new tasks and ability to effectively operate within a fast-paced environment
Strong interpersonal, written and oral communication skills
Must be able to consistently demonstrate appropriate confidentiality, integrity and sensitivity in handling all investigation matters
Proficient with Microsoft Office
Advanced Regulatory requirements - US and EU GMP
Demonstrated experience in managing/handling product quality complaints
Qualifications:
Education - Bachelor's degree in applicable scientific field (Quality Management, Pharmaceutical Engineering, Chemistry) preferred
Work Experience - Minimum 10-15 years experience working in a Quality Assurance Department. Pharmaceutical industry investigative/compliance experience is preferred.
Other - Knowledge of French language desired, but not required. Quality Auditor certification preferred. Experience with a Quality Management System preferred.
Physical Requirements:
Must be able to communicate, write legibly and understand English
Visual Inspection
Working Conditions:
N/A
Travel Required:
Up to 40% with some international travel
This job description is intended to convey information essential to understanding the scope of the job and general nature and level of work performed by job holders within this job. This job description is not intended to be an exhaustive list of qualifications, skills, duties and responsibilities or working conditions associated with the job. This job description is not an employment contract. Ceva reserves the right to modify job duties and/or job descriptions at any time to meet the needs of the business.
*VEVRAA Federal Contractor
**Ceva is an equal opportunity employer and all qualified applicants will be considered for employment without regard to race, color, religion, sex, national origin, age, genetic information, actual or perceived sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law. Ceva encourages men and women, members of all racial and ethnic groups, individuals with disabilities and veterans to apply.
685C
#USCEVA
Yourprofile :
Education - Bachelor's degree inapplicable scientific field (Quality Management, Pharmaceutical Engineering,Chemistry) preferred
Work Experience - Minimum 10-15 years experience working in aQuality Assurance Department. Pharmaceutical industry investigative/complianceexperience is preferred.
Other - Knowledge of Frenchlanguage desired, but not required. QualityAuditor certification preferred. Experience with a Quality ManagementSystem preferred.
The success of a company depends on the passionate people we partner with.
Together, let's share our talents.
As a global leader in animal health, Ceva Animal Health believes our success is linked to our passionate people researching, developing , producing and supplying innovative health solutions for all animals, which contributes to the future of our diverse planet.
We are committed to ensuring the highest possible level of care and well-being for farm animals (poultry, pigs, ruminants), companion animals (dogs and cats) and wildlife.
Indeed, Our "Together, Beyond Animal Health" vision emphasizes that the health and wellbeing of people, animals and our planet are totally interlinked. More than ever, Ceva is committed to a "One Health" approach.
As part of our "Diversity, Equity and Inclusion" policy, Ceva Animal Heath is committed to the employment of people with disabilities and will make reasonable accommodations throughout the interview process to ensure an inclusive and accessible experience for all applicants. To request an accommodation, please contact a member of the Ceva Talent Acquisition team.
Yourmissions :
Location: Lenexa, KS
Job Summary and Purpose:
This position will oversee and manage Quality Assurance and Product Compliance in accordance with the applicable regulatory requirements (e.g. GMP's for US FDA, Canada, EU, and US-EPA) and Ceva corporate guidelines. The successful candidate must possess a high level of experience and knowledge of pharmaceutical industry regulatory guidelines and ability to interact effectively with contract manufacturer's (CMO's) and product distribution organizations. The 3rd Parties QA Specialist will assess the risk to Ceva regarding quality matters and communicate the potential risks to Ceva upper management.
Responsibilities and Key Duties:
Quality Assurance through Audits and Investigation
Perform external audits for Ceva activities ensuring the preparation of complete, concise and timely investigated reports
Ensure CAPA, change control activities are followed-up and closed out properly
Perform qualifying and oversight audits of CMOs who manufacture, package, and test EPA, FDA veterinary pharmaceutical products or products with other applicable regulations or guidelines
Develop and manage a system to ensure all quality investigations and audit deficiencies are properly abated
Receive CMO related complaints, evaluating them as product quality defects, supply chain
Responsible for investigations with CMO into product diversion and related issues
Document Management
Under limited supervision, implement and administer a Standard Operating Procedures ("SOP") program aligned to proper regulatory and business practice requirements
Write and/or edit SOPs pertaining to the Quality Assurance responsibilities and duties
Ensure consistency and appropriate storage of documents
Provide Quality Oversight of Ceva Contractors
Write Quality Agreements for CMOs. Review and approve critical GMP documents from the CMO (e.g. MBR, specifications)
Receive notification of Quality Issues from contractors; assess the risk to Ceva, communicate risk factors to Ceva management. Develop appropriate risk management strategies
Work with contractors to investigate Quality issues, assess root cause and develop effective CAPA; plan and coordinate annual quality meetings with critical contractors
Develop Key Quality Performance Indicators for Ceva contractors; define with contractors metrics on their KPIs and communicate them to Ceva Management
Review product annual reports and investigational information for regulatory compliance and quality risk
Provide regulatory guidance and expertise
Core Competencies:
Shape solutions out of complexity - Is open and curious of other perspectives
Client focus - Has in mind client's satisfaction
Collaborate with empathy - Has a positive attitude towards collaboration
Engage and develop - Clarifies short-term directions
Drive ambition and accountability - Proactively manages own and others work
Influence others - Communicates effectively
Technical / Functional Competencies:
Ability to maintain a professional demeanor even when confronted with stressful and/or potentially adversarial situations
Demonstrated ability to effectively interact with multiple cross functional teams (IT, HR, Regulatory, Customer Services, Sales, Legal, Field Sales, vendors, etc.)
Must be capable of simultaneously handling multiple tasks and project deadlines
Demonstrated flexibility, willingness to take on new tasks and ability to effectively operate within a fast-paced environment
Strong interpersonal, written and oral communication skills
Must be able to consistently demonstrate appropriate confidentiality, integrity and sensitivity in handling all investigation matters
Proficient with Microsoft Office
Advanced Regulatory requirements - US and EU GMP
Demonstrated experience in managing/handling product quality complaints
Qualifications:
Education - Bachelor's degree in applicable scientific field (Quality Management, Pharmaceutical Engineering, Chemistry) preferred
Work Experience - Minimum 10-15 years experience working in a Quality Assurance Department. Pharmaceutical industry investigative/compliance experience is preferred.
Other - Knowledge of French language desired, but not required. Quality Auditor certification preferred. Experience with a Quality Management System preferred.
Physical Requirements:
Must be able to communicate, write legibly and understand English
Visual Inspection
Working Conditions:
N/A
Travel Required:
Up to 40% with some international travel
This job description is intended to convey information essential to understanding the scope of the job and general nature and level of work performed by job holders within this job. This job description is not intended to be an exhaustive list of qualifications, skills, duties and responsibilities or working conditions associated with the job. This job description is not an employment contract. Ceva reserves the right to modify job duties and/or job descriptions at any time to meet the needs of the business.
*VEVRAA Federal Contractor
**Ceva is an equal opportunity employer and all qualified applicants will be considered for employment without regard to race, color, religion, sex, national origin, age, genetic information, actual or perceived sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law. Ceva encourages men and women, members of all racial and ethnic groups, individuals with disabilities and veterans to apply.
685C
#USCEVA
Yourprofile :
Education - Bachelor's degree inapplicable scientific field (Quality Management, Pharmaceutical Engineering,Chemistry) preferred
Work Experience - Minimum 10-15 years experience working in aQuality Assurance Department. Pharmaceutical industry investigative/complianceexperience is preferred.
Other - Knowledge of Frenchlanguage desired, but not required. QualityAuditor certification preferred. Experience with a Quality ManagementSystem preferred.