Principal Specialist, QA
Boehringer Ingelheim, Colbert, GA, United States
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 We support our employees in several ways to foster a healthy working environment, meaningful work, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.
The Principal Specialist, QA provides support at the GI site to ensure the integrity and compliance of GI outputs intended for regulatory submissions. This role supports the Site Quality Head (SQH) to ensure that the site is ready for GxP regulatory inspections.
Duties & Responsibilities
Supports Deviations, Investigations and CAPA Process, and change controls opened and their potential impact
Participates in working groups aiming at harmonizing and improving QS processes and/or serves as local GIQA project representative on Q projects
Ensures the QA review of GMP study documents or GMP GI batch production documents that will be required for the registration and/or validation of methods developed by GI to ensure GMP compliance
Local Inspections and Audits
Participates in the organization, execution and follow up of GxP inspections and audits. Inspections and audits may include internal audits of GI facilities and systems for compliance with international regulatory directives and corporate, divisional, and departmental policies and procedures
Supports the follow-up of CAPA plan
Conducts third party audits for local suppliers
Where applicable, conduct in-process GCP/GLP audits (e.g., critical phase inspections, investigate site audits or similar) and prepare reports within defined timelines
Depending on gained experience, may also lead fewer complex audits
May serve as local management system owner (LMSO) for supplier qualification at the respective site
Documentation
Provides QA review for local quality system document
Reviews and approves as QA the necessary procedures in place to cover GI GxP activities (e.g., SOP, specifications)
Ensures compliance of facilities and equipment by reviewing the appropriate documentation (e.g., validation, logbook, qualification report.)
Training
Supports the conduct of training to GI personnel to ensure knowledge of regulations, guidelines, and standard operating procedures
If required, also supports conduct of other quality training as per identified needs
Depending on gained experience, may also conduct training of GI personnel
Process Improvement
Supports identification of opportunities for improvements as well as gains approval for and implement quality improvements
Provides timely and accurate reporting of appropriate measures of quality performance to GI management (e.g., KPIs, QMRs).
Requirements
BA/BS in chemistry, life sciences, pharmacy or a related field or equivalent education with minimum of five (5) years’ professional experience in a relevant domain.
Three (3) years prior experience conducting audits as auditor or comparable experience as auditee in the pharmaceutical, biological or equivalent industry.
Experience conducting audits in the pharmaceutical, biological, or equivalent industry.
Ability to work in a project team environment.
Rigor, autonomy, organization in the work, ability to work in a team, good interpersonal skills, proactivity, strength of conviction.
Good understanding in working in cross-functional projects and environments.
Excellent communication skills in local language (spoken and written), good communication skills in English.
Good knowledge in GxP.
General understanding of quality assurance and quality management. Experience in supporting internal audits
Excellent verbal and written communication skills.
Skillful in using office application software (MS-Word, MS-Excel, MS-Outlook)
Eligibility Requirements
Must be legally authorized to work in the United States without restriction.
Must be willing to take a drug test and post-offer physical (if required).
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The Principal Specialist, QA provides support at the GI site to ensure the integrity and compliance of GI outputs intended for regulatory submissions. This role supports the Site Quality Head (SQH) to ensure that the site is ready for GxP regulatory inspections.
Duties & Responsibilities
Supports Deviations, Investigations and CAPA Process, and change controls opened and their potential impact
Participates in working groups aiming at harmonizing and improving QS processes and/or serves as local GIQA project representative on Q projects
Ensures the QA review of GMP study documents or GMP GI batch production documents that will be required for the registration and/or validation of methods developed by GI to ensure GMP compliance
Local Inspections and Audits
Participates in the organization, execution and follow up of GxP inspections and audits. Inspections and audits may include internal audits of GI facilities and systems for compliance with international regulatory directives and corporate, divisional, and departmental policies and procedures
Supports the follow-up of CAPA plan
Conducts third party audits for local suppliers
Where applicable, conduct in-process GCP/GLP audits (e.g., critical phase inspections, investigate site audits or similar) and prepare reports within defined timelines
Depending on gained experience, may also lead fewer complex audits
May serve as local management system owner (LMSO) for supplier qualification at the respective site
Documentation
Provides QA review for local quality system document
Reviews and approves as QA the necessary procedures in place to cover GI GxP activities (e.g., SOP, specifications)
Ensures compliance of facilities and equipment by reviewing the appropriate documentation (e.g., validation, logbook, qualification report.)
Training
Supports the conduct of training to GI personnel to ensure knowledge of regulations, guidelines, and standard operating procedures
If required, also supports conduct of other quality training as per identified needs
Depending on gained experience, may also conduct training of GI personnel
Process Improvement
Supports identification of opportunities for improvements as well as gains approval for and implement quality improvements
Provides timely and accurate reporting of appropriate measures of quality performance to GI management (e.g., KPIs, QMRs).
Requirements
BA/BS in chemistry, life sciences, pharmacy or a related field or equivalent education with minimum of five (5) years’ professional experience in a relevant domain.
Three (3) years prior experience conducting audits as auditor or comparable experience as auditee in the pharmaceutical, biological or equivalent industry.
Experience conducting audits in the pharmaceutical, biological, or equivalent industry.
Ability to work in a project team environment.
Rigor, autonomy, organization in the work, ability to work in a team, good interpersonal skills, proactivity, strength of conviction.
Good understanding in working in cross-functional projects and environments.
Excellent communication skills in local language (spoken and written), good communication skills in English.
Good knowledge in GxP.
General understanding of quality assurance and quality management. Experience in supporting internal audits
Excellent verbal and written communication skills.
Skillful in using office application software (MS-Word, MS-Excel, MS-Outlook)
Eligibility Requirements
Must be legally authorized to work in the United States without restriction.
Must be willing to take a drug test and post-offer physical (if required).
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