Pharmaceutical Recruiting Quality Validation Engineer at Germer International
Pharmaceutical Recruiting in Center Valley, Pennsylvania Posted in 1 day ago.

Type:

full-time

Job Description:

Quality Validation Engineer Essential Duties and Responsibilities :

Arranges, plans, manages and executes installations, operations and performance qualifications of packaging, laboratory and utility system sSchedules, plans, manages and executes studies for cleaning validation sSchedules, plans, manages, and executes process validation studies and authoring related plans, summary reports and protocol sReviews and approves validation project documentatio nCoordinates and interfaces with the process unit heads, quality and engineering groups to ensure successful project execution sLeads and coordinates cross-functional teams for project validatio nPriorities, manages and executes multiple projects utilizing the project management methodologie sOversees external validation resource sSupports the development of best and proven validation practices in the validation department based on current industry guidelines and practice sAuthors relevant standard operating procedures for ensuring compliance with the company's policie sSupports regulatory submissions and also regulatory agency inspections whenever requeste dChampions continuous improvements in the validation departmen tKey Competencies (knowledge, skills and abilities every person must possess to be successful )cGMP and Regulatory Compliance

Strong understanding of pharmaceutical cGMP, industry standards, and regulations to make sound regulatory interpretation, lead and/or conduct investigations, employ logic, and implement decisions from within the Quality Assurance organizatio nProfessional Communication
Excellent verbal and written communication skills with the ability to interact across functions, departments, and seniority level sComputer Literacy
Knowledge of and ability to use Microsoft Outlook, Excel, and Word, as well as other web-based system sCollaboration
Utilize teamwork and problem solving skills across all departments and internally to Quality Assuranc eProject Management
The ability to lead projects in relation to all quality functions including identify issues, initiate successful corrective actions, and completion of all tasks in timely manne rEducation / Experienc eBachelor's degree or higher in relevant scientific/technical fiel d

Total Combined Years:

4 or more years within industry or Regulatory/Compliance, including project management experience preferre dExperience in project managemen tMust be well organized with a keen attention to detai lKnowledge of the various state and federal pharmaceutical validation laws and legislations that are enforced from time to tim e","accountId","0","Germer International - Pharmaceutical Recruiting","https://www.disabledperson.com/jobs/74235627-quality-validation-engineer","location",{"_441":442,"_443":444},"status","active","isDiscoverable","isSearchable","isSpotlight","isDraft","careerSkills",[384,385,386,387,388,389,390,391,392,393,394,395,396,397,398,399,400,401],"requiredEducation","4_college","isEmailRequired","isPhoneRequired","titleSearch","Quality Validation 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