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Boehringer Ingelheim · 1 day ago

Principal Specialist, QA

Athens, GA

Full-time

Onsite

Senior Level, Lead/Staff

5+ years exp

Boehringer Ingelheim is a global leader in healthcare, committed to improving lives through innovation. The Principal Specialist, QA role involves ensuring the integrity and compliance of GI outputs for regulatory submissions, supporting the Site Quality Head in preparing for GxP inspections, and participating in audits and quality system documentation.

BiotechnologyHealth CareMedicalPharmaceutical

Comp. & Benefits

No H1B

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 GMP compliance during project development phases at local level

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

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

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, ...)

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

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)

Qualification

GxP complianceAuditing experienceQuality assuranceProject team collaborationCommunication skillsProactivityOffice application softwareInterpersonal skillsOrganizational skills

Required

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)

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)

Must be 18 years of age or older

Company

Boehringer Ingelheim

Glassdoor4.2

Boehringer Ingelheim is a group of pharmaceutical companies that focuses on prescription medicines and animal health. It is a sub-organization of Boehringer Ingelheim.

Founded in 1885

Ingelheim Am Rhein, Rheinland-Pfalz, DEU

10001+ employees