Technology Pharmacist

AstraZeneca•Canóvanas, PR

About The Position

Coordinate and conduct process development, process validation and/or cleaning validation activities to assist in process improvement and optimization. Provide technical support for the introduction of new products, product transfer, technology and/or processes. Supports manufacturing operations. As technology pharmacist, will represent IPR Pharmaceuticals, Inc in the corresponding forums, support the site license maintenance and regulatory inspections. On call for pharmaceutical operations feedback, if required.

Requirements

Fifth year college or university program certificate in Pharmacy or other sciences and over seven (7) years related experience and/or training. Thorough knowledge of the pharmaceutical industry with emphasis in manufacturing, process development and validation.
Fully Bilingual (English & Spanish).
Knowledge of MS Word, MS Excel, MS Project, MS Power Point, among others.
Puerto Rico Licensed Pharmacist required to serve as site’s regent pharmacist.
Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret and extensive variety of technical instructions in mathematical or diagram model and deal with several abstract and concrete variables.
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.

Nice To Haves

Specialized courses in statistics desirable.

Responsibilities

Coordinate projects activities assigned by the Team lead.
Review documents generated by the work group as delegated by Team lead.
Review accuracy of master formulas and approve as required.
Represent Technology Services team in company/project groups as delegated.
As required, represent Technology Services at international workshops related to new products, technology transfer, process/cleaning validation, etc.
Authorized designee for review and approval of Bill of Materials related to products manufactured.
In the absence of the Technology Services Associate Director, authorized designee to approve master production documents.
Periodically reviews strategy for the implementation of assigned projects.
Serve as project leader for special projects beneficial to the business needs.
Design technically sound experiments to identify and work with variables that could possibly affect new and/or current products/processes.
Develop, execute and report clearly defined programs to provide documented evidence of validated processes, cleaning procedures and/or equipment.
Participate in manufacture of experimental, validation, stability and/or clinical batches within established time frame.
Oversees the manufacture of experimental, validation, stability and/or clinical batches if that is the role assigned.
Oversees the cleaning experimental and validation activities as well as annual monitoring if that is the role assigned.
Conduct assessment and troubleshooting activities to resolve technical problems of routine manufacturing operations nature.
Provides technical support in the selection of processing equipment.
Perform and report physical test results of validation and/or experimental samples. Carryout in depth statistical analyses as required, towards continuous improvement or process optimization.
Establishes or adjusts work procedures to meet project schedules using effective project management techniques.
Makes recommendations to Technology Services Associate Director or Manufacturing Operations team members for optimization of manufacturing/cleaning processes to ensure robustness and thus reliability beyond process/cleaning validation.
Recommends measures to improve production methods, equipment performance, and quality of products.
Generate and/or revise SOPs/CIRs on a frequent basis to ensure compliance with standards. Provide training in revised SOPs/CIRs as required.
As required, participate in audits; assists in preparation of audit report.
Prepare and/or review Manufacturing Orders.
Participates in review of Chemistry and Pharmacy Dossiers. Assists in the analysis and problem resolution and assisting other team members.
Represents Technology Services in the hazard studies conducted and in meetings as delegated by the Technology Services Associate Director.
Serves as site’s regent pharmacist for the Puerto Rico Health Department with primary accountability for licensure.
Responsible for the Puerto Rico Health Department regulatory inspections and documentation.
Prepares own professional development plan and submits for discussion and approval.