Compliance Auditor 2
Compliance Auditor 2
Org Marketing Statement
All over the world, Pfizer colleagues are working together to positively impact health for everyone, everywhere. Each position at Pfizer touches and contributes to the success of our business and our world. That’s why, as one of the global leaders in the biopharmaceutical industry, Pfizer is committed to seeking out inspired new talent who share our core values and mission of making the world a healthier place.
This position is responsible for interpreting the GMP regulations / guidelines and the Pfizer Quality
Standards and ensuring that the site remains compliant with these requirements.
You will ensure realization of the site audit plan by conducting internal audits
and inspections and ensuring the follow-up on corrective actions. You will report your
findings in a clear, precise and factual way.
In this role you are responsible for suggesting and evaluating changes to the site’s quality
system. You work closely with departments outside QA to improve overall quality and
make sure that site personnel are properly trained/qualified to perform their assigned duties.
You will contribute to the continuous improvement of the internal processes and may be asked to
participate in Quality related Project teams.
You will report to the Quality Systems Manager.
Act as Quality authority for approving purchasing Supplier Evaluation Reports.
Manage Approved Supplier List
Manage Supplier Quality Agreements
Perform site specific supplier audits as needed.
Manage internal audits and the site Quality Assurance Self-Assessment (QASA) program to include scheduling, mentoring auditors, reviewing QASA reports etc.
Assist in follow up of action items generated from QASA
Work with Pfizer Global Supply groups (center functions, other sites) as needed
Assist with preparation and/or facilitation of regulatory inspections as needed
Other duties within the quality department as required.
EDUCATION AND EXPERIENCE
Bachelor's degree in a technical field i.e. Biology, Chemistry, Engineering, Pharmacy and a minimum of four years related experience or equivalent combination of education and experience.
Minumum three years of experience in a pharmaceutical production environment
Audit experience is a must
Experience in aseptic manufacturing is preferable.
Experience with preparation and/or facilitation of regulatory inspections (FDA, EMA, … ) is preferable.
ASQ Certified Qaulity Auditor is preferable.
TECHNICAL SKILLS REQUIREMENTS
Experienced in auditing with GMP regulated industries
Knowledge of aseptic manufacturing
Knowledge of Quality Systems in pharmaceutical industry
Knowledge of Medical Devices is an asset
Fluent in English both speaking & writing
Good knowledge of MS Office
Good analytical and investigation skills
PHYSICAL POSITION REQUIREMENTS
This position may require overtime and some off -hour work to support Manufacturing.
While performing the duties of this job, the employee is occasionally exposed to work near moving mechanical parts. The noise level in the work environment is usually moderate. While performing the duties of this job, the employee is occasionally required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms and talk or hear; ability to lift up to 25 lbs; sometimes exposed to loud noise. Specific vision abilities required by this job include ability to distinguish colors and to adjust focus.
Some travel will be required to satisfy site specific audits.
Position requires regular onsite attendance – this position cannot be performed on a remote or telecommute basis on a temporary, short or long term basis.
Must have the ability to simultaneously multi-task across multiple capabilities and functions and handle multiple competing priorities and requirements, including performing site and functional responsibilities, responding to frequent e-mail and phone communications and attending multiple meetings and conference calls. Note that these activities may not be time bound to core hours or presence at the site.
Must have the ability to work effectively under and manage to strict production, time and performance deadlines.
Must be willing and able to work beyond the hours typically defined as a “regular” workday, which may or may not include weekends and holidays.
Equal Employment Opportunity
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment.
This job is open only to Lawful Permanent Residents (as defined by 8 U.S.C. §1101(a)(20)), or Protected Individuals (as defined by 8 U.S.C. §1324b(a)(3), namely, U.S. Citizens, Refugees, and Asylees.
Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.
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Desired Skills and Expertise
2 - 5 years
Salary / package