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The person in this role is responsible of provides technical support, and coordinates activities and projects of the quality documentation, assuring compliance with established standards and regulations. Coordinate and implement the site Quality Management Responsibility requirements such as Annual Product Reviews and Management reviews. Appointed Regent Pharmacist for the site; responsible for coordination/monitoring of activities related to the Jayuya site
ESSENTIAL DUTIES AND RESPONSIBILITIES
Execute and coordinate all company tasks associate to Plant Pharmacist Be the Regent Pharmacist.
Assure that the site complies with all requirements established for Quality Management Responsibility including review and implement any requirements modifications. Coordinate and perform all activities required to create and maintain the Site Quality Manual, Site Master File, and Site Quality Plan.
Assure compliance with company procedures, quality and regulatory requirements, and guidance including, Quality System (QS), cGMP regulations, and guidelines.
Provide technical support in complaints investigations, including customer meetings and/or sales representative contacts in product use impact, when request.
Coordinate, participate and perform communication, meetings or teleconference with company department or facilities, as required.
Review of Annual Product Report and support the report preparation, when request.
Keeps site Pharmaceutical license up to date and owns this process while interacting with PR government agencies.
Provide the reports to the appropriate company groups on time.
Provide support to the Quality Manager during the FDA inspections, and other audits, when required.
Able to work under minimum supervision and to handle multiple tasks at the same time.
Occasionally required to work extra hours, Holidays, (e.g. shutdown, FDA Audits, clients and others).
Performs visits to areas of responsibility, document findings and suggestions to improve processes.
Revises, implements changes and audits existing specifications and SOP's; creates new ones as required.
It will serve as a delegate when so requested by their Manager.
Support additional quality related items, when request.
Team Work oriented.
Willing to travel.
QUALIFICATIONS
EDUCATION and/or EXPERIENCE
Bachelor Degree in Pharmaceutical Science with 5 years’ experience, or Pharma D with 2-4 years’ experience. Preferable knowledge in CGMP 21 CFR Part 210 and 211. Required Puerto Rico active pharmacist license.
LANGUAGE SKILLS
Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, internal and external audits, and other departments. Fully bilingual in Spanish and English languages.
MATHEMATICAL SKILLS
Ability to work with mathematical concepts such as probability and statistical analysis. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
REASONING ABILITY
Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral diagram or schedule form.
CERTIFICATES, LICENSES, REGISTRATIONS
Require P.R. active pharmacist license, cGMP's trainings and other trainings, certificates or license that immediate supervisor refers.
COMPANY REGULATORY COMPLIANCE
Observes and promotes company security, industrial hygiene, cGMP's, procedures and other security measures already established by the company; should inform any violation.
PHYSICAL DEMANDS
While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee occasionally required to stand; walk; use hands to finger, handles, or feel reach with hands and arms; and climb or balance. The employee must occasionally lift and/or move up to 20 pounds. Specific vision abilities required by this job includes close vision, and color vision.
WORK ENVIRONMENT
While performing the duties of this job, the employee is occasionally exposed to wet and/or humid conditions, and/or extreme cold, extreme heat. The noise level in the work environment is usually moderate. Should be able to work at any shift when it is required.
SAFETY EQUIPMENT and/or EQUIPMENT
While performing the duties of this job, the incumbent use computer, telephone, company procedures and policies, office supplies, copy machine fax machine, calculator. The incumbent is required to use the appropriate Safety Equipment that Baxter requires to comply with all Safety and Security rules (in Regulated Areas), such as: safety glasses, safety shoes, uniform, special safety suit, gloves, and any other equipment necessary in order to protect the health and safety of the incumbent.
DISCLAIMER STATEMENT
The above statement is intended to describe the general nature a level or work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of personnel so classified.
Equal Employment Opportunity
Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
EEO is the Law
EEO is the law - Poster Supplement
Pay Transparency Policy
Reasonable Accommodations
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to ********** and let us know the nature of your request along with your contact information.
