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Computer System Validation Csv Pharmaceutical Jobs in Alabama

Pharmacist - Prov Pharmacy - Providence

Mobile, AL · On-site

$57.75 - $69.50/hr

Participates in studies, quality monitors and drug evaluations to improve pharmaceutical care and clinical outcomes * Performs patient care activities on the pharmacy computer system in a safe and ...

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Computer System Validation Csv Pharmaceutical information

What is computer system validation (CSV) in the pharmaceutical industry?

Computer System Validation (CSV) in the pharmaceutical industry is a process used to ensure that computerized systems used in drug manufacturing and related processes work as intended and comply with regulatory standards, such as FDA 21 CFR Part 11. CSV involves planning, testing, documenting, and maintaining systems to guarantee the accuracy, reliability, and integrity of data. This is critical for patient safety and product quality, as well as for meeting legal and regulatory requirements. The process typically includes risk assessment, validation planning, protocol execution, and ongoing monitoring of system performance.

What are common challenges faced by computer system validation (CSV) professionals in the pharmaceutical industry?

CSV professionals in the pharmaceutical industry often encounter challenges such as keeping up with evolving regulatory requirements, managing documentation for audits, and ensuring thorough validation of complex systems within tight project timelines. Collaboration with cross-functional teams, such as IT, quality assurance, and manufacturing, is essential to address technical and compliance issues. Additionally, balancing the need for robust validation with operational efficiency requires strong communication and project management skills.

What are the key skills and qualifications needed to thrive as a computer system validation (CSV) professional in the pharmaceutical industry?

To thrive as a Computer System Validation (CSV) professional in pharmaceuticals, you need a strong background in life sciences or engineering, knowledge of regulatory standards (such as FDA 21 CFR Part 11), and experience with validation protocols. Familiarity with validation lifecycle management tools, quality management systems (QMS), and industry guidelines like GAMP 5 is typically required, along with certifications such as ISPE or PMP being advantageous. Outstanding attention to detail, analytical thinking, and strong communication skills help ensure compliance and effective coordination with cross-functional teams. These competencies are vital for maintaining regulatory compliance, data integrity, and patient safety in pharmaceutical operations.

What is the difference between Computer System Validation Csv Pharmaceutical vs Quality Assurance Specialist?

AspectComputer System Validation Csv PharmaceuticalQuality Assurance Specialist
CertificationsGxP, 21 CFR Part 11, Validation certificationsGxP, ISO, QA certifications
Work EnvironmentPharmaceutical manufacturing, regulated labsQuality departments across industries, including pharma
Employer & IndustryPharmaceutical companies, biotech firmsPharma, biotech, healthcare organizations
Primary FocusEnsuring computer systems meet validation and compliance standardsMaintaining quality standards and process improvements

Computer System Validation Csv Pharmaceutical specialists focus on validating computer systems to ensure compliance with industry regulations, while Quality Assurance Specialists oversee overall quality processes. Both roles require GxP knowledge and are vital in pharmaceutical environments, but their core responsibilities differ in scope and focus.

What are popular job titles related to Computer System Validation Csv Pharmaceutical jobs in Alabama?

For Computer System Validation Csv Pharmaceutical jobs in Alabama, the most frequently searched job titles are:

What job categories do people searching Computer System Validation Csv Pharmaceutical jobs in Alabama look for?

The top searched job categories for Computer System Validation Csv Pharmaceutical jobs in Alabama are:

What cities in Alabama are hiring for Computer System Validation Csv Pharmaceutical jobs?

Cities in Alabama with the most Computer System Validation Csv Pharmaceutical job openings:

Pharmacist - CW Pharmacy - Children's and Women's Hospital

USA Health Systems

Mobile, AL

$57.25 - $68.75/hr

Full-time

Posted 24 days ago


Job description

Overview

USA Health is Transforming Medicine along the Gulf Coast to care for the unique needs of our community. USA Health is changing how medical care, education, and research impact the health of people who live in Mobile and the surrounding area. Our team of doctors, advanced care providers, nurses, therapists, and researchers provides the region's most advanced medicine at multiple facilities, campuses, clinics, and classrooms. We offer patients convenient access to innovative treatments and advancements that improve the health and overall well-being of our community.

Responsibilities
  • Assists pharmaceutical activities and functions related to medication use and monitoring for all patient care areas according to departmental and hospital guidelines
  • Participates in studies, quality monitors and drug evaluations to improve pharmaceutical care and clinical outcomes
  • Performs patient care activities on the pharmacy computer system in a safe and timely manner
  • Utilizes a personal computer or terminal to access the Hospital Information System or the Pharmacy Purchasing System
  • Performs general pharmacy duties as needed by filling and dispensing medications
  • Prepares and dispenses IV solutions and compounds medications including Chemotherapy
  • Dispenses controlled substances as defined by the controlled substance permit
  • Confirms accuracy of work performed by pharmacy technician, including unit dose carts
  • Reviews physician's orders for appropriate route, dose, scheduling and potential drug interactions and consults physicians as needed
  • Serves as a resource for medical and nursing staff regarding pharmaceutical activities
  • Provides information on medications for patients as needed
  • Encourages pharmacy and physician staff to use Formulary medications
  • Communicates and uses appropriate customer relation skills with physicians, patients, families and healthcare team in person and via telephone
  • Responds to overhead pages
  • Maintains accurate and complete records
  • Utilizes the correct documentation tools and procedures for all pharmacy functions
  • Maintains proper records for all medications and controlled substances dispensed or received
  • Accepts and completes all duties positively and without conflict
  • Cooperates, helps others and improves the performance of the department; completes all mandatory department, educational and hospital requirements
  • Maintains orderliness and cleanliness of work areas, equipment and supply areas
  • Abides by and enforces all compliance requirements and policies and performs these responsibilities in an ethical manner consistent with the organization's values
  • Adheres to hospital policies including confidentiality
  • Ttrains and orients new pharmacy employees to the department and their job functions
  • Safely performs essential functions with minimum supervision
  • Utilizes proper body mechanics when moving equipment and supplies that is necessary to perform essential functions
  • Maintains and operates equipment and reports broken or malfunctioning equipment
  • Adheres to current Infection control and safety standards
  • Utilizes cost effective practices in performing all aspects of the job
  • Demonstrates the ability to provide competent patient care to Neonate, Infant-Toddler/Preschool, School age/Adolescent, Reproductive age and Post/Peri Menopausal patient population
  • Participates on committees as assigned
  • Performance improvement activities through quality measurement or participation of ICARE process as assigned
  • Accesses and accurately maintains electronic and paper medical records
  • Completes all mandatory department, educational and hospital requirements
  • Adheres to current Infection Control and Safety Standards
  • Regular and prompt attendance
  • Ability to work schedule as defined and overtime as required
  • Related duties as assigned
Additional Information

Employees must be in a regular position, working 20 hours or more per week (.50 FTE or greater) to qualify for benefits.

Qualifications
  • Graduation from a recognized school of Pharmacy as approved and accepted by the University of South Alabama Required
  • RPH - Registered Pharmacist - Licensure with the State of Alabama to practice pharmacy Required and
  • CONSUBS - Pharmacist Control Substance Licensure with the State of Alabama to dispense Controlled Substances Required
  • Completion of an approved Alabama Board of Pharmacy IV certification program within 90 Days Required
  • Comparable combination of education and experience may substitute for the above requirements.
Employment Type: FULL_TIME