Baxter provides a broad portfolio of essential renal and hospital products, including home, acute and in-center dialysis; sterile IV solutions; infusion systems and devices; parenteral nutrition; surgery products and anesthetics; and pharmacy automation, software and services. The company’s global footprint and the critical nature of its products and services play a key role in expanding access to healthcare in emerging and developed countries. Baxter’s employees worldwide are building upon the company’s rich heritage of medical breakthroughs to advance the next generation of healthcare innovations that enable patient care.
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. Creates, improves and audits SOP's and Protocols to assure are in compliance with all internal specifications and regulatory requirements.
Essential Duties and Responsibilities
- Execute and coordinate all company tasks associate to Plant Pharmacist responsibilities, updating registrations, among others.
- Be the Regent Pharmacist
- Assure compliance with company procedures, quality and regulatory requirements, and guidance including GLP, QSR, cGMP, USP, and CDR rules, regulations, and guidelines. Serve as a technical expert and interface with investigators during both internal and external inspections.
- Support the Internal and External Audit program through: conducting internal audits, review and approval of investigations due to an observation, preparing responses to the MOH agencies.
- Support the complaint program through: execution and/or approval of investigations, updating reports and escalation issues that may require a Field Alert or Field Action.
- Support the stability program through: review and approval of stability studies conducted.
- Support regulatory requests through: preparation of documents to be submitted to regulatory agencies, coordinating registration samples.
- Coordinate, support, review and approve the Out of Specification investigations, non-conformance report and/or CAPA records and assure comply with corporate, division and local procedures.
- Prepare statistical, quality reports, quality indicators and accountability items to track progress and measure improvements.
- Support validations performed through the plant. Ensure completion of all protocols and validations in a timely and appropriate manner. Report progress of protocols, validation work and significance of results.
- Support Change Control program through: Manage the Change Document Review process, local procedures update, documentation forms update, etc.
- Prepare, review and revise, as required, SOPs and specifications. Audits, creates and implements changes to specifications and SOP's. Write memos, reports, protocols, CPAs and other appropriate documentation for proper functioning of the department.
- Performs weekly, monthly and annual reports as required by policies and procedures.
- Work with minimum or no supervision. Work or handle multiple tasks and projects simultaneously. Team worked oriented.
- The pharmacist should be able to communicate at all Plant and Divisional levels.
- Observe and promote company security, industrial hygiene, cGMP's, procedures and other security measures already established by the company; should inform any violation.
- Willing to Travel
Qualifications for this role
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, clients, internal or external audits and other departments. Fully bilingual (English and Spanish).
Ability to work with mathematical concepts such as probability and statistical analysis (SPC). Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
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.
Education and Experience
- Bachelor Degree in Pharmacy. Licensed Pharmacist. Doctor of Pharmacy degree from an accredited college or university is preferred.
- Must have an extensive experience (minimum 10 years) in the Healthcare product industry and in the development, implementation and assessment of Quality Assurance and compliance programs for GMP's and FDA regulation guidelines and activities
- Minimum of five years manufacturing plant experience with exposure to MOH, regulations and guideline compliance is required.
A Career That Matters
Baxter’s employees are united in a mission to save and sustain lives. We are passionate about applying scientific innovation to meet the needs of the millions of people worldwide who depend on our medically necessary therapies and technologies. We focus on increasing access to healthcare, innovating in crucial areas of unmet need, and pursuing creative collaborations that bring our mission to life for patients every day.
EEO is the law - Poster Supplement
Pay Transparency Policy
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 Americas_TTA@baxter.com and let us know the nature of your request along with your contact information.
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.