Published: October 9, 2019
- Responsible for the supervision and technical support of Document Control, Record Retention and Lot Release departments and associated processes.
- Licensed Regent Pharmacist responsible for overseeing day to day operations to ensure that are compliant with State Pharmacy Law and applicable regulation requirements.
- Assures departmental compliance with Corporate, Federal (QSR's, FDA), International (ISO), and other applicable regulatory agency requirements (i.e. OSHA).
- Interacts with the company personnel Division to follow up and resolve issues related to documentation.
- Provides technical support to assure the timely maintenance, update and operation of the facility documentation system.
- Assures continuity of departmental service during regular working day office hours with an adequate staff, fully cross training in the Document Control, Records Retention and Lot Release department functions.
- Maintains a state of control within the department in regard to but not limited to DMR's, CR's, Deviations, Validations and secondary documents as applicable.
- Participates as required in the Plant Validation Program.
- Assures is trained before performing any task
- Uses the required clothes, personal and security protective equipment according to the requirements of its operation.
- Complies with the cGMP’s, Quality Standards and established policies and/or procedures.
- Executes other duties assigned by the supervisor.
- Licensed Pharmacist in Puerto Rico, active
- Knowledge of fundamental Quality System principles such as CAPA, Investigations and Management Reviews
- Thorough knowledge of QSR's, cGMP's, OSHA and ISO regulations
- Computer Literate: Microsoft Office (Power Point, Word, Excel) among others
- Must be bilingual (English/Spanish) and must have good communication skills both oral and written
- Team work oriented
- Must be able to develop procedures, specifications, drawings within the requirements of the documentation system.
- Demonstrated ability to plan and manage multiple projects.
- Excellent interpersonal skills including the ability to interface and communicate effectively at all levels, both inside and outside the organization.