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Qualified Person and Senior Manager


Hurley, WI 54534
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Job Details

**Qualified Person** **Hurley**

QP drug certification and release activities include lots received from both Hospira and third party manufacturing facilities, both within and outside the EU. The function serves to conduct remote, virtual batch certification and release activities on associated lots.

**Compliance and Integrity:**

You will be responsible for conducting your activities on behalf of the company consistent with a high standard of business ethics and in compliance with the laws and regulations that govern our activities. Your obligation encompasses the following:

+ Takes personal responsibility for and demonstrates a high level of understanding of and adherence to the applicable internal policies, including but not limited to our Code of Ethics and Business Conduct and other policies applicable to your job, and external laws and regulations governing your activities.

+ Exhibits high business ethics standard in dealing with internal and external stakeholders, including dealing with others honestly and openly, showing accountability, being reliable and trustworthy and being loyal to the company.

+ Completes all required compliance and ethics related training within required timelines.

+ Encourages a high level of understanding of and adherence to compliance and ethics amongst colleagues and third parties.

+ Fully co-operates in any internal and external audits, investigations and inspections

**Essential Job Functions:**

+ Eligible to act as a European Qualified Person, certifying products in compliance with 2001/93/EC, 2003/94/EC and Annex 16, with relevant experience in Sterile Injectable dosage form manufacture and testing

+ Execute drug product batch certification and release functions in compliance with 2001/93/EC, 2003/94/EC and Annex 16

+ Review of batch manufacturing records and other documentation associated with QC release in conjunction with QA Officers. Checking that batch manufacturing records comply with registered details and EU GMP standards. Investigating any differences or issues found upon review of the batch manufacturing records and rectifying problems in conjunction with relevant sites and personnel.

+ Assists in the resolution of supply chain issues, such as product shortages, competent authority notifications and represents site at senior management meetings (as required)

+ Work in partnership with internal stakeholder and functional groups supporting supply to market

+ Provides support for global manufacturing sites and Pfizer internal departments (regulatory, operations etc)

+ Liaise directly with Regulatory Agencies such as the MHRA (as required). Assisting in the preparation for and hosting of regulatory agency inspections, coordinates responses and ensures commitments are maintained.

+ Executes assigned internal self-inspections, Quality Risk Management program, external audits, visits and assigned activities within the vendor management program.

+ Issues QP Declarations of GMP compliance.

+ Reviews, feedback and approves APQR documents.

+ Develops and agrees both global and local quality agreements with vendors as needed.

+ Co-ordinates any external tests by third parties whilst ensuring that they are performed in accordance with GLP/GMP guidelines, standards of Pfizer and the European Pharmacopoeias and USP recommendations

+ Providing leadership in European regulations ensuring GMP knowledge of self and others within both the QA team and site is developed and applied.

+ Maintain CPD in conformance with agreed plans and contributes to the sites training program (as required)

+ Represents Pfizer in outside global technical groups and where required presents papers at external meetings.

+ Provides support as required to routine departmental release requirements, covers other QPs when absent from the office in the execution of both QP duties and QA management.

+ Implements and maintains assigned systems relative to Quality such as Procedures, Technical agreements, Validation, Change Control, Exception Reports / Deviations, Complaints, Internal Audits, External Audits & visits, Good Distribution Practice and Recalls.

+ Provide guidance in the identification of process improvements

**Experience & Knowledge Required:**


+ Bachelor's degree in a related scientific discipline with relevant experience (Biology/Chemistry/Pharmacy/Life Sciences)

+ Trained as QP with experience in pharmaceutical materials.

+ Experience of API manufacture, primary compounding, primary and secondary packaging and release, preferred.

+ Experience in validation of facilities, utilities, equipment, processes, analytical methods

+ Extensive knowledge of GMP & GDP

+ Eligible to act as a QP in association with an MIA license.

+ QA Management / line management experience

+ Ability to apply technical knowledge and understanding to making appropriate and timely risk based decisions.

Specialist knowledge & experience:

+ Biotechnology / Biologics / Sterile injectable manufacture

+ Manufacture of novel dosage forms

+ Secondary / outsourced packaging activities

+ Global manufacture and supply chains

**Closing Statement**

This position holds a UK Salary Grade 12

We will only accept applications via the formal route within WorkDay.

Please do not submit paper or e-mail applications.

In line with good development planning, colleagues should discuss their suitability and/or

readiness for a vacancy with their line manager prior to application. Colleagues are required to

inform their manager if they are invited to attend interview. Where a line manager is not able to

support an application either for suitability, readiness or business reasons, and a colleague

continues to make an application, it is possible that an offer may not be made or may be


All applicants must have the relevant authorisation to live and work in the UK.

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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