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PMI Service Center Europe
PMI Service Center Europe
location iconLocations: Kraków
level iconLevel: manager/director
APPLY AS
Always Inspection Readiness Manager
Location: Kraków

MAKE HISTORY WITH US!

At PMI, we’ve chosen to do something incredible. We’re totally transforming our business, and building our future on smoke-free products with the power to improve the lives of a billion smokers worldwide.

With huge change, comes huge opportunity. So, wherever you join us, you’ll enjoy the freedom to dream up and deliver better, brighter solutions and the space to move your career forward in endlessly different directions.

As an Always Inspection Readiness Manager you will be responsible for specific preparation of selected entities for upcoming regulatory (i.e. FDA) inspections, including but not limited to Define Role & Responsibility, Collect and verify check list for inspections, Identify SME, define knowledge gap and coach, Drive planning and execution of mock audits and of response to mock audits findings.

JOIN US!

WHO ARE WE LOOKING FOR?

• A person with a University degree with degree in Engineering, Chemistry or related field
• A candidate with 8+ years working experience in Quality Assurance in pharmaceutical industries or medical device industries
• A candidate with 10+ years working experience in GXP environment in pharmaceutical industries or medical device industries
• A person with profound knowledge in US GXP and EU regulations relevant for audit/inspections, qualification/validation, compliance systems
• A person with excellent communication and decision making skills
• An individual with proficient in providing solutions for complex challenges
• A candidate with good problem analysis and problem solving with quality tools
• Ability to work independently in a team environment
• Past experience in working within a cross-functional, multidisciplinary and project team oriented environment to ensure project and business alignment
• Highly collaborative person, integrator, strong communicator and influencer holding very good business awareness
• An individual with creativity and fact based analytical skills
• A person with technical writing skills, ability to communicate technical knowledge in a clear and understandable manner
• A person with fluent command in English, both written and spoken

WHAT WE OFFER YOU?

• Private medical and dental care, life insurance
• Company car / or car allowance
• Subsidized meals in company canteens or Sodexo card while working remotely
• Remote work opportunity and flexible working arrangements
• Employee pension plan
• Multisport program
• Wide range of trainings, optional language classes, further education and professional qualification support possibility
• Free bike and car parking for all employees

HOW CAN YOU MAKE HISTORY WITH US?

• By assessing and assisting critical stakeholders in quality compliance aspects
• By leading review of NC/CAPA/Changes, ensuring quality of records, effectiveness of action planned
• By supporting strategy for Inspection Readiness Model deployment and drive execution for selected entities
• By driving increase of Inspection Readiness Maturity Level for selected entities and identify need of the transfer of know-how and knowledge accordingly
• By overseeing delivery of action plan, response plan and training
• By advocating, promoting and transferring know-how and coach on guiding principle on inspection readiness and quality compliance
• By supporting management of regulatory Inspections and lead Integration process
• By supporting PMI entities during regulatory (i.e. FDA) inspections. Drive planning and execution of response to inspections findings
• By identifying applicability of findings for other PMI entities
• By leading Inspection Readiness process across PMI selected entities
• By supporting interaction with regulatory authorities
• By verifying review of documentation to be sent to Regulatory Bodies (Submission of full Package/Annual Report/Inspection Response/ and related correspondence)
• By supporting routine interaction with regulatory authorities to ensure successful regulatory inspection
• By collaborating to increase level of compliance of processes supporting Inspection Readiness Model deployment execution
• By reviewing of critical quality records, perform compliance checks (NC/CR/Audit Findings/Complaints/Recall) & Provide guidance on NC, Change, CAPA and Exception Management
• By verifying and ensuring quality of records, effectiveness of remediation
• By supporting strategy for effective QMS deployment and for building PMI quality culture and capabilities
• By coordinating reporting and follow-up on open NC/CAPA/changes
• By ensuring execution of selected escalated NC/CAPA/changes
• By providing various support to AIR Quality Compliance Manager

Please note that only on-line applications will be taken into consideration.

Only selected candidates will be contacted.


Details

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  • iconKraków, małopolskie

Company profile

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locationKraków
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