Validation Manager - Pharma

skyeblue consulting; Hickory (NC); On-site; USD 70,000 - 90,000; Full time

Job summary

Skye Blue Consulting is seeking a Validation Manager for a growing pharma firm in Western North Carolina. The role involves managing the Validation/Calibration department and ensuring quality data processing across multiple study sites.

The ideal candidate will hold a Bachelor’s degree, have 3-5 years of relevant experience, and possess knowledge in various software applications. Competitive salaries and excellent benefits are offered.

Qualifications

• 3-5 years related experience and/or training.

Responsibilities

• Manages all aspects of the Validation/Calibration department.
• Designs and implements systems to assure quality of data processing across study sites.
• Works with database designers to set up computer systems.
• Performs routine testing for product release and stability studies.
• Helps develop lab documents to support compliance with GMP.
• Performs routine procedures to monitor adherence to guidelines.

Skills

Database software

Statistical software

Project Management software

Spreadsheet software

Word Processing software

Knowledge of US Pharmacopeia/National Formulary analytic methods

Statistical Process Control (SPC)

Design of Experiments (DOE)

Education

Bachelor’s degree from a four‑year college

Advanced degree preferred

Job description

Skye Blue Consulting has been engaged to find a Validation Manager for one of our top clients in Western North Carolina. The client is a small (but growing) pharma firm with competitive salaries, great benefits and is located in the beautiful foothills area.

Job Description

Job Task(s)

• Manages all aspects of the Validation/Calibration department.
• Designs and implements systems to assure quality of data processing across multiple study sites.
• Works with database designers to set up computer systems.
• Performs routine testing for product release and stability studies.
• Helps develop lab documents to support compliance with GMP.
• Performs routine procedures to monitor adherence to guidelines.

Computer Skill(s)

• Should have knowledge of Database software; Statistical software; Project Management software; Spreadsheet software and Word Processing software.
• Knowledge of US Pharmacopeia/National Formulary analytic methods: Knowledge of SPC and DOE is desired but not required.

Qualifications

Education Requirements

• Bachelor’s degree (B.A.) from a four‑year college or equivalent combination of education and experience. An advanced degree is preferred.

Work Experience Requirements

• 3-5 years related experience and/or training.

Physical Demand(s)

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is frequently required to sit and talk or hear. The employee is occasionally required to stand; walk and use hands to finger, handle, or feel. Specific vision abilities required by this job include close vision and ability to adjust focus.

Additional Information

All your information will be kept confidential according to EEO guidelines.