Hiring company: Pfizer
Why Patients Need You
Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.
What You Will Achieve
You will be a member of Pfizer’s dedicated and highly effective Regulatory Compliance team. You will be responsible for activities involved in developing and maintaining quality programs, processes and procedures that ensure compliance with established standards and agency guidelines.
It is your hard work and commitment that will make Pfizer ready to achieve new milestones and help patients across the globe.
How You Will Achieve It
- Interfaces with site departments in the coordination of audit planning and post audit activities; including but not limited to, fulfilling pre-requests, scheduling staffing support of the inspection, active participation in the inspection, writing responses, evaluation of robustness of responses and CAPAs received from departments and submitting responses to agency/ customer.
- Potential interactions and communications with the regulatory agencies/ customers.
- Participates in regulatory inspections, assessments and customer audits, as appropriate. Participates in the development and delivery of auditor training, and regulatory inspection preparedness training.
- Support of the Commitment Tracking Model of the CAPA Management system, including Initiator, Responsible Person, and/or Approver of records
- Evaluates applicable corrective and preventive action responses to the audit findings for adequacy and timeliness. Assesses and approves closure of CAPAs within the CAPA Management system as the QA Approver for audit gQTS records.
- Reports on weaknesses, ineffective procedures, policy exceptions and discrepancies and, as needed, recommends appropriate corrective actions.
- Actively participates in continuous improvement initiatives to align with business strategies.
- As needed, leads or participates in self-audit preparation, resolution of self-audit findings and liaises with auditing groups and audit stakeholders through all stages of the audits.
- Maintenance of the management of the Quality Improvement Plan (QIP) for the site. This includes but not limited to, prepares the QIP governance presentation for the site on a set frequency, integrates continuous improvements of the QIP, and lead CAPA Audit Commitment meetings.
- Support of the Inspection Readiness Program. Prepares the Inspection Readiness presentations, lead the Inspection Readiness meetings and responsible for maintenance of follow up actions to ensure the actions are executed in a timely manner.
- Support of the Compendial Compliance Program
- Support of the following: Site Master File, Site Regulatory Inspection Plan, State License Program, and Risk Assessment Issuance/ Retention.
- Supports the preparation, revision, and implementation of relevant SOPs.
- Supports all compliance responsibilities.
Qualifications
Must-Have
- Bachelor’s Degree with 4 years of related experience in a GMP FDA regulated work environment
- Minimum of 4 years of experience in one or more of the following:- Quality Engineering/Compliance/Regulatory Affairs
- Manufacturing/ Technical experience in Pharmaceutical or GxP regulated environment
- Demonstrated ability to work/ contribute in a team-based environment as a lead and a participant with exceptional interpersonal skills and demonstrated problem-solving skills
- Thorough knowledge and understanding of the pharmaceutical regulations and guidelines, including but not limited to cGMPs, GLPSs, ICH, USP, FDA and other applicable industry guidelines.
- Strong organizational, presentation, meeting facilitation and technical writing skills
- Possess attention to detail and good communication skills as verbal and written feedback to the site SMEs is required when reviewing/approving audit responses for completeness and robustness
- Strong computer proficiency skills in MS Office, Word, Excel, CAPA management system or equivalent
Nice-to-Have
- ASQ-CQA certification preferred.
- Knowledge of the audit processand the ability to interpret audit observations and provide guidance in audit responses
- Internal Lead Auditor certification within 1 year of hire
PHYSICAL/MENTAL REQUIREMENTS
- Ability to work extended hours, especially during health authority inspections, assessments and audits.
- Allow for flexibility in shifts to accommodate ad-hoc assignments on an as needed basis
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
- Ability to support internal audits as needed
- Adherence to safe work practices and procedures by applying appropriate safety and PPE measures as needed.
Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.
Sunshine Act
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.
EEO & Employment Eligibility
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 as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.