Maintain and assure full compliance of the following Quality Systems: Standard Operating Procedures Program, Distribution of product specification for raw materials, packaging materials and finished products; Change Management Program, Approval of Batch Records and Standard Operating Procedures. Oversee Quality System to assure fulfillment compliance with Pfizer Quality Standards and site procedures
- Provide guidance to operating managers and supervisors in resolving quality and documentation problems.
- Responsible for the assurance and maintenance of master batch records and standard operating procedures and for the distribution of material specifications and laboratory testing method.
- Review and approve new product/technology transfer plans and related documents which include but are not limited to, Process Validations, Equipment Qualification, Computer System, Commissioning and Qualification Documents, as required.
- Responsible for the compliance of current Good Manufacturing Procedures during the execution of their functions.
- Responsible for Site’s Documentation Systems. This includes
- Specifications and test method Distribution
- Master batch records issuance
- Provide support through Regulatory Inspections readiness and processes
- Review and approve SOP’s.
- Review and approve Product Change Requests and CAPAS and assures that required technical documentation, as required.
- Provide recommendation on utilities readiness from Quality perspective.
- Track and follow-up until completion for regulatory commitments.
- Other functions can apply as deemed necessary by Quality Management.Specific training will be provided prior to perform those functions.
- Actively participate in the definition of validation strategies for the products manufactured and/or packaged in Vega Baja
- Responsible for the Supplier Qualification Program.
- Coordinate the issuance and approval of Annual Product Review Reports.
- Coordinate and monitor Product Stability program at the Site Level.
- Develops and reinforces with key quality personnel effective goal setting, both short and long term, to ensure that quality performance is maintained at optimum level.
- Reinforces a quality philosophy with location management to assure that product meets established company specifications and promotes the Pfizer Values.
- Appraises or evaluates appraisals, in writing, of the job performance of each of the colleagues within his/her department, at least annually and in accordance with established procedures and ensures that appraisal is discussed with employees.
- Prepares and administers the salary and variable expense budget for his/her department responsibilities. Establishes systems whereby expenditures are assessed for adherence to plan. Manages the yearly budget effectively.
- Prepares capital projects approvals and plans for his/her department with appropriate justifications to permit purchase and installation of necessary instruments, etc. Adheres to budgeted items and dollars.
- Ensures that adequate standards of safety, health and environmental (EHS) exist regarding personnel, facilities and equipment within the quality department.Participates in the Safety Program as established by the Environmental, Safety & Health Department.
- Continues his/her professional and administrative development through attendance to seminars, graduate courses, and other appropriate formal educational programs.
- Develops and implements management and other techniques that would allow job growth and enrichment concepts.Brings the opportunity of professional development for his/her subordinates to assume additional responsibilities.
- Assists during regulatory inspections (FDA, Department of Health, etc.).
- Supports the company’s environmental programs, following the established policies and procedures and corporate environmental policies.
- Ensures that all environmental practices applicable to his/her respective areas of responsibility are followed according to area SOPs and company environmental compliance policies and guidelines.
- Ensures Controlled Substances are managed according to DEA requirements and following internal SOP’s.
- Participates in Technology Transfer Meetings to ensure that customers are informed of the documentation requirements.
- Review existing location Quality Systems to improve the quality of our products through prevention using statistical, six sigma and other quality tools for analysis.
- Makes recommendations about manufacturing and packaging processes and as a result determine whether or not the location is operating in compliance with current GMP and Regulatory requirements.
- Bachelor’s degree in Chemistry, Biology or other Science, Engineering or Pharmacy.
- Over 10 years of experience in pharmaceutical industry (solid technology experience and people management is required).
- Full knowledge of related governmental regulations and its regulatory agencies (cGMP, FDA, DEA, EMA, etc.)
- Expertise with documentation computerized systems (PDOCS, Trackwise) highly desirable.
- Strong background in quality assurance matters, laboratories and validation of processes and systems
- Fully bilingual both, verbal and written (English and Spanish)
- Available to provide on call support during weekends and after working hours.
- Willing to work irregular hours, weekends and holidays when necessary.
- Demonstrated business acumen
- Acts Decisively
- Seizes accountability
- Holds people accountable
- Grows others
- Leads change
- Self Awareness
- Build Effective teams
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.
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.
Last Date to Apply for Job: January 17, 2019
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.