SR Specialist, QA Auditing - Boehringer Ingelheim
Athens, GA
About the Job
Description
Leads and conducts internal audits to assess the quality / compliance of current Good Manufacturing Practice (cGMP), applicable regulations, and applicable company policies and procedures. May support or lead small scale audits of external suppliers and contractors on behalf of the BIAH-US facilities and external suppliers and contractors on behalf of the BI manufacturing world, including Operations, Development, Biopharma, and Animal Health. Ensures corrective measures are implemented. Provides transparency of risks from non-compliance. Assesses the implementation and execution of quality / GMP standards at suppliers and contractors to meet FDA/EU and other relevant regulatory requirements, and to prevent and mitigate quality risks.As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies´ success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim´s high regard for our employees.
Duties & Responsibilities
+ Schedule, plan and prepare for internal audits of Operations, Development, Biopharma and Animal Health facilities for BI operating units and external audits of suppliers and contractors
+ Lead and conduct internal audits of Operations, Development, Biopharma and Animal Health facilities for BI operating units.]
+ May support or lead small scale external audits of suppliers and contractors.
+ Prioritize and self manage audit and inspection tasks
+ Create and issue audit report for each audit to submit to management as a means to ensure SOPs, facilities, systems, processes and studies conform to applicable cGMP, Good Laboratory Practices (FDA. USDA, EU), Good Clinical Practices (FDA), and/or Guidance Documents (FDA, USDA, EU) internally and for external contract manufacturers, laboratories and suppliers
+ Perform follow-up actions, including over-site of compliance issues noted during audits and inspections or otherwise observed or reported
+ Plan, perform, document and conduct required post-audit activities for assigned internal and external audits to ensure timely closer of CAPAs
+ Communicate deviations from the cGMP or other Regulations observed during audits/inspections, recommend appropriate corrective action when necessary and verify that appropriate corrective actions have been implemented that adequately address any deviations reported during audits to BI Quality Management
+ Resolve quality concerns and implement quality improvements by meeting with other department Managers to assure current methods, procedures or SOPs meet current standards
+ Develop, review and/or approve documents associated with Supplier Quality Management (eg. change controls, specifications, compliance certifications, etc.)
+ Enable global quality overview of BI suppliers, challenge their status and identfy gaps/risks for BI's Supply Chain Integrity
+ Practice GMP for APIs, excipients and Good Distribution Practice and Pharmaceutical products (GDP)
Requirements
+ Requires a Bachelor´s Degree from an accredited institution in relevant field of position.
+ Requires a minimum of three (3) years´ experience in quality or auditing in a GMP regulated environment.
+ A Quality Engineer / Auditor certification from ASQ or equivalent preferred. Qualification as a Lead Auditor preferred.
+ In-depth knowledge of relevant regulations and guidances required.
+ In-depth knowledge of Quality Systems and related norms (e.g. ICH 8/9/10, ISO 9000 series).
+ In-depth knowledge of cGMP.
+ Willing and able to travel at least 25% of the time.
+ Must possess demonstrated organizational skills that have proven results in the ability to be self-directed.
+ Strong independent judgment and decision making abilities required.
+ Excellent analytical skills.
+ Must possess excellent verbal and written communication skills
+ Excellent conflict resolution and negotiation skills.
+ Knowledge of process improvement concepts and applications in compliance environment.
+ Respectful interactions with individuals with diverse views or backgrounds.
+ Skillful in using office application software (MS-Word, MS-Excel, MS-Outlook).
Desired Skills, Experience and Abilities
All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.
Leads and conducts internal audits to assess the quality / compliance of current Good Manufacturing Practice (cGMP), applicable regulations, and applicable company policies and procedures. May support or lead small scale audits of external suppliers and contractors on behalf of the BIAH-US facilities and external suppliers and contractors on behalf of the BI manufacturing world, including Operations, Development, Biopharma, and Animal Health. Ensures corrective measures are implemented. Provides transparency of risks from non-compliance. Assesses the implementation and execution of quality / GMP standards at suppliers and contractors to meet FDA/EU and other relevant regulatory requirements, and to prevent and mitigate quality risks.As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies´ success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim´s high regard for our employees.
Duties & Responsibilities
+ Schedule, plan and prepare for internal audits of Operations, Development, Biopharma and Animal Health facilities for BI operating units and external audits of suppliers and contractors
+ Lead and conduct internal audits of Operations, Development, Biopharma and Animal Health facilities for BI operating units.]
+ May support or lead small scale external audits of suppliers and contractors.
+ Prioritize and self manage audit and inspection tasks
+ Create and issue audit report for each audit to submit to management as a means to ensure SOPs, facilities, systems, processes and studies conform to applicable cGMP, Good Laboratory Practices (FDA. USDA, EU), Good Clinical Practices (FDA), and/or Guidance Documents (FDA, USDA, EU) internally and for external contract manufacturers, laboratories and suppliers
+ Perform follow-up actions, including over-site of compliance issues noted during audits and inspections or otherwise observed or reported
+ Plan, perform, document and conduct required post-audit activities for assigned internal and external audits to ensure timely closer of CAPAs
+ Communicate deviations from the cGMP or other Regulations observed during audits/inspections, recommend appropriate corrective action when necessary and verify that appropriate corrective actions have been implemented that adequately address any deviations reported during audits to BI Quality Management
+ Resolve quality concerns and implement quality improvements by meeting with other department Managers to assure current methods, procedures or SOPs meet current standards
+ Develop, review and/or approve documents associated with Supplier Quality Management (eg. change controls, specifications, compliance certifications, etc.)
+ Enable global quality overview of BI suppliers, challenge their status and identfy gaps/risks for BI's Supply Chain Integrity
+ Practice GMP for APIs, excipients and Good Distribution Practice and Pharmaceutical products (GDP)
Requirements
+ Requires a Bachelor´s Degree from an accredited institution in relevant field of position.
+ Requires a minimum of three (3) years´ experience in quality or auditing in a GMP regulated environment.
+ A Quality Engineer / Auditor certification from ASQ or equivalent preferred. Qualification as a Lead Auditor preferred.
+ In-depth knowledge of relevant regulations and guidances required.
+ In-depth knowledge of Quality Systems and related norms (e.g. ICH 8/9/10, ISO 9000 series).
+ In-depth knowledge of cGMP.
+ Willing and able to travel at least 25% of the time.
+ Must possess demonstrated organizational skills that have proven results in the ability to be self-directed.
+ Strong independent judgment and decision making abilities required.
+ Excellent analytical skills.
+ Must possess excellent verbal and written communication skills
+ Excellent conflict resolution and negotiation skills.
+ Knowledge of process improvement concepts and applications in compliance environment.
+ Respectful interactions with individuals with diverse views or backgrounds.
+ Skillful in using office application software (MS-Word, MS-Excel, MS-Outlook).
Desired Skills, Experience and Abilities
All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.
Source : Boehringer Ingelheim