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Quality Assurance Officer


Hurley, WI 54534
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Job Details

Reporting to a Quality Manager, Provide day-to-day assistance for commercial QA activities associated with remote/virtual batch disposition. The QA officer will ensure assigned tasks are performed in a timely manner to meet batch disposition, supply chain and all associated international GMP/GDP requirements.KEY DUTIES AND RESPONSIBILITIES:

Batch Release

Weight 70%

To compile & review batch document sets for completeness & compliance to EU GMP, Pfizer internal requirements and regulatory dossier submissions

To resolve manufacturing, testing, packaging and supply chain issues to support batch disposition

To complete all relevant documentation to support the QP in the release of drug products

To assist the certifying QP in the release of the drug product where required within Pfizer systems

QA Support (Quality Systems)

Weight 30%

To assist in maintenance of quality systems including complaint handling, deviations/exception reporting, change control, supply agreements, document control, complaint handling, quality metrics reporting, temperature excursion resolution, document control and retention systems, training as determined by the Quality Manager.

Project execution and support as required.

Experience or Required Knowledge


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

+ Basic experience in pharmaceutical manufacturing, distribution and control measures

+ Basic experience in Quality administered systems. Previous use of Trackwise QMS beneficial.

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

+ Able to demonstrate good planning and organisation skills

+ Attention to detail and accuracy - able to follow verbal and written instruction (SOP's).

+ Quality and process orientation and mindset

+ Possession of good verbal and written communication skills

+ Ability to accept responsibility and be pro-active within defined limits

+ Excellent system skills - Word and Excel essential, experience with electronic documentation control systems advantageous.

+ Enthusiastic, positive individual driven to meet targets and standards

+ High level of self- integrity and ethical conduct

Specialist knowledge & experience (desirable):

+ Sterile injectable manufacture

+ Manufacture of novel dosage forms

+ Secondary / outsourced packaging activities

+ Global manufacture and supply chains

+ New product launches & commercial supply chain

The closing date for the role is 22nd November 2017

This role holds a UK Grade 5

**Location & Travel:**

The 10% travel requirement is associated with the position supporting activities within the manufacturing and supply chain as directed by line management.

**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

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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