Pharm Tech Inc. Work Values

Daily Duties at Pharm Tech Inc.:

• Medical Device projects: o Experience writing and executing validation documentation for various processing units in the medical device industry, including recipe generation software, assembly stations, Microsoft SQL server production and reporting database, and visicon inspection station. o Managed document numbers and structure for the validation of a new production system, including six production lines in two countries. o Utilized SQL queries to change and obtain data from database during execution. o Developed and wrote process gap assessment documentations for a manual medical device manufacturing line. Performed function of site lead on the site, preparing weekly status reports and managing day-to-day completion of work. • Designed and wrote internal standard operating procedure system to standardize projects • Cleaning Validation project: o Wrote standard operating procedures based on the client’s cleaning validation protocols o Spent two months working third shift at the client site to resolve issues to finish the cleaning validation. o Reviewed and edited final reports created from the execution of cleaning validation protocols • Traceability Matrices project: o Wrote traceability matrices to show that all important data in specifications was tested o Managed flow of documents to and from client o Traveled to client site to oversee document flow • Recipe Operation Qualifications: o Spent five months at client site writing, testing, and executing Operation Qualifications for the manufacture of a blood product used to treat emphysema. These recipes were automated using Intellution iBatch and iFix. o Served as Study Director for the two most complex recipes, organizing the writing, execution, and discrepancy resolution of the recipes o Used knowledge of cGMPs to write Operation Qualifications • Daily Equipment Log: o Wrote Validation Plan for the validation of Daily Equipment Log, a Visual Basic based computer software program implemented at the client site. o Ensured that validation of the Daily Equipment Log was compliant with 21 CFR part 11 • Buffer and Clean-In-Place Operation Qualification Review: o Reviewed written Operation Qualifications for automated buffer production and clean-in-place processes used to make a blood product for treating emphysema. o Managed the document flow between employees at the client site and employees in the PharmTech office. o Wrote four of the clean-in-place operation qualifications from specifications.

What they like about Pharm Tech Inc.:

You give high priority to hiring firms with prestige. Market reputation and prestige of a firm may be determined through on-line research, and conversations with individuals working in your target industry. Note that firms "in the public eye" receive a great deal more critical publicity and attention than those operating with more anonymity. So as you assess your employment opportunities, be sure to seek out the positive aspects of the firm's reputation in addition to noting negative publicity the company may have received.

Tags

validation, cGMP, 21 CFR part 11, Part 820

Skills

P&L responsibilities, Presentation, Ecommerce Strategy and digital marketing channels optimization - SEO, SEM, email, affiliates - for high-profile accounts., Technology Solutions, Sales Support, Software Implementation, Requirements Analysis & Specification, Leadership

These are some of the questions we asked our climbers about their experiences with Pharm Tech Inc.: