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Computer System Validation Csv Pharmaceutical Jobs in Iowa

Pharmacist

Sioux City, IA · On-site

$57.50 - $69.25/hr

Enters TPN orders into compounder computer system accurately and timely. Qualifications Education ... Valid driver's license when driving any vehicle for work-related reasons req uired

This client is a German multinational Pharmaceutical and biotechnology company and one of the ... Civil and Mechanical system design decision making. * Applying sound project design engineering ...

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Computer System Validation Csv Pharmaceutical information

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 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 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.
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$57.50 - $69/hr

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Re-posted 21 days ago


Job description

We are looking for an efficient, flexible, and highly motivated Float Pharmacist to join our team at our retail Medicap Pharmacies in Northeast Iowa based out of Waterloo, IA!

Under indirect supervision, the Pharmacist will provide a full range of patient services in our retail and compounding pharmacies.  They may include filling prescriptions, counseling patients, supervising Pharmacy Technicians, preparing medications including measuring, mixing, counting, labeling, and recording amounts and dosages of medications, providing professional services, and assuring that all services comply with professional standards and applicable laws.  

ESSENTIAL DUTIES AND RESPONSIBILITIES

The following duties are normal for this position. These are not to be construed as exclusive or all inclusive. Other duties may be required and assigned.

  • Follows all company policies and procedures including register performance, security issues, and confidentiality.
  • Ensures the correct formula preparation according to the prescription following quality assurance guidelines for compounding preparation.
  • Uses proper compounding and labeling techniques emphasizing pharmaceutical elegance when making medications.
  • Prepares medications including emulsions, liquids, powders and ointments.
  • Follows proprietary formulations to compound commercially unavailable prescriptions into the appropriate dosage form
  • Verifies compound and documentation. Places and confirms that the beyond use date on the patient’s product label is correct.
  • Ensures all relevant steps in each compound are verified.
  • Orders, labels, and counts inventory of medications, chemicals, and supplies, and enters inventory data into pharmacy computer software.
  • Maintains product inventory by reordering materials/products necessary for compounding processes.
  • Properly cleans work area and equipment upon completion of daily compounding. Ensures the compounding lab and related equipment are cleaned and maintained according to policy
  • Correctly uses and maintains all equipment necessary for preparing compounded products.
  • Routinely checks for outdated or soon to expire chemicals, commercially available products and compounded products
  • Selects proper packaging for compounded products i.e. correct bottle size, tube size, etc.
  • Understands and locates Material Safety Data Sheet “MSDS” guidelines for maintaining safety and managing safety events.
  • Locates and demonstrates general knowledge of Standard Operating Procedures (“SOP’s”).
  • Uses proper garbing techniques in accordance with SOP guidelines.
  • Understands and follows all USP 795/800 guidelines.
  • Interprets written prescriptions, checks for drug interactions and allergies, enters prescription and patient data into computer system, and gives prescription information to Pharmacy Technician for filling. Supervises Technicians, checks all work for accuracy.
  • Serves patients by counseling over the phone and in person. Conveys pertinent information regarding how and for how long the medication should be taken. Answers patient’s questions. Consults with other health care professionals and conducts research as necessary to ensure that all services are in the best interests of the patient and conform to established professional standards and applicable state laws.
  • Ensure proper billing occurs when pharmacist on duty in compliance with insurance plan, CMS, and/or board of pharmacy.
  • Counsels’ patients to ensure that patients understand their treatment program and to ensure that treatment goals are being met. Meets face to face with patients, discusses disease state and treatment options. Answers questions to ensure patient understanding.
  • Maintains current state pharmacy license.
  • Maintains working knowledge of all aspects of the computer and cash register.
  • Maintains store competitiveness and profitability by controlling operational expenses and maximizing sales.
  • Maintains regular and punctual attendance. Develops courteous and professional relationships with patients, customers, and co-workers.
  • Comply with all security/loss prevention procedures including setting alarm, securing safe, etc.
  • Maintain a perpetual schedule II inventory
  • Complete third-party rejections
  • Maintain daily and weekly reports
  • In cases of dispensing incidents, follow company procedures: notification and report completed
  • Ensure compliance with all company procedures and federal and state laws, rules, and regulations.
  • Performs other duties as assigned.

EDUCATION and/or EXPERIENCE

  • Minimum Bachelor's level degree in Pharmacy OR PharmD from accredited Pharmacy College.
  • Active and unrestricted Pharmacy license in the state
  • One to two years related experience; or equivalent combination of education and experience.
  • Strong interpersonal and customer service skills