Job description
Summary
Responsibilities include execution of Qualification Protocols related to equipment, computers, and facilities under the supervision of the site Validation Engineers. Secondary responsibilities include drafting Validation Qualification Protocols and Nonconformances related to equipment, process and facilities under the supervision of a Validation Engineer. In addition, the position may require drafting Summary Reports for executed protocols. The duties of this position directly impact company compliance to regulatory requirements and customer satisfaction.
Essential Duties and Responsibilities
The following is a list of minimum responsibilities related to this position. Other duties may be assigned.
- Executing qualifications and validation protocols at a designated site.
- Documenting the evaluation of all work-in-process components at defined intervals.
- Documenting the evaluation of finished protocols at defined intervals.
- Documenting the evaluation of machinery on the packaging line to ensure product integrity. This includes verification of component status prior to use.
- Participating in internal, customer, and regulatory audits at the discretion of senior management.
- Draft IQ/OQ protocols for appropriate equipment, systems, and processes within guidelines of cGMP and GAMP
- Draft Nonconformances for executed protocols for appropriate equipment, systems, and processes within guidelines of cGMP and GAMP.
- Draft Confirmation of Changes for appropriate equipment, systems, and processes within guidelines of cGMP and GAMP and obtain approval and closure of Change Controls.
- Draft summary reports for executed IQ/OQ protocols under the supervision of a Validation Engineer.
- Communicate and participate actively in team meetings.
- Maintain compliance with cGMP and all competent authority guidelines by regularly reviewing and adhering to SOPs
- Adhere to set safety standards.
- Achieve expected performance measures.
- Other duties as assigned.
Qualifications
To perform this job successfully, an individual must be able to perform each essential duty. The requirements listed below are representative of the knowledge, skill, and/or ability required.
- Associates or Bachelor’s degree is preferred with one to three years related experience and/or training or a High School Degree with six to ten years related experience and/or training.
- Experience in inspection of pharmaceutical or related industry is desired.
- General knowledge of FDA regulations related to GAMP and cGMPs is required.
- General knowledge of quality control/assurance is required.
- Good documentation and communications skills are required.
- Good organizational and planning skills are required
- Demonstrated ability to work independently, handle multiple tasks simultaneously and meet critical timelines.
- Basic math skills (addition, subtraction, multiplication and division) are required. Ability to apply moderately complex mathematical operations including an understanding of statistical sampling plans and the ability to calculate time, percentages, and decimals is required.
- Excellent oral and written communication is required to communicate with the team, peers, management and external contacts.
- Basic Windows applications to include MS Word, MS Excel and MS Outlook.
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