Description

Perrigo is the world's largest manufacturer of over-the-counter pharmaceutical and nutritional products for the store brand and contract manufacturing markets and an emerging developer, manufacturer and marketer of prescription generic drugs.

Reporting to the Quality Assurance and Compliance Manager, this position acts as the primary Quality Unit Investigator, Reviewer and Approver for cGMP documentation and studies conducted in manufacturing. This includes, but is not limited to SOPs, change controls, deviation investigations, manufacturing and packaging batch records, validation data and summaries, and annual product review data. The incumbent ensures that information and documentation conforms to Perrigo policy and cGMPs and all other applicable FDA guidances. This includes:

- Providing leadership in the development and implementation of procedures, processes and documents that are used to ensure the Companys quality standards are met and maintained.
- Investigating, reviewing and approving Temporary Changes, Quality Incidents/Deviations, stock status change requests, Annual Product Reviews, Calibration Non-conformances, cGMP observation review, and Line Trials.
- Entering data into a CAPA system that will be used to identify trends and/or root causes; they shall also be responsible for participating in comprehensive investigations as necessary.
- Ensuring that all corrective and preventive actions created are consistent with the Companys Standard Operating Procedures.
- Providing final disposition of deviation investigations consistent with company SOPs.
- Working with operations, laboratory, engineering, and maintenance managers and staff to develop evaluate and implement action plans which maintain or improve product and process quality.
- Leading or participating in quality driven initiatives in the continuous support of Quality Improvement.
- Holding suspect products until investigations or authorization for release have been provided and will ensure that quality standard deviations are investigated, documented, and approved prior to disposition of product.
- Providing off-shift support for quality event risk assessment and resolution on an on-call basis.
- Providing Technical support for all products at the site.

Requirements

A Bachelors degree in a scientific or technical discipline is required. Relevant work experience in Quality Assurance is highly desirable. Minimum three years experience in and substantial knowledge of manufacturing, packaging and quality testing systems in a pharmaceutical environment is required. Familiarity with cGMP, FDA regulations and pharmaceutical manufacturing/ packaging is required. Excellent analytical skills and the ability to interpret and apply FDA regulations to company operating procedures are necessary. Excellent communication skills are essential, including well developed interpersonal skills, the ability to work effectively with staff members at all levels, and strong technical writing skills. Prior professional experience in inspection, quality control, and release in a pharmaceutical manufacturing environment is preferred. Computer literacy is required.


The policy of the Perrigo Company has been and continues to be to provide and ensure equal advancement and employment opportunities for all qualified individuals without unlawful discrimination based on race, national origin, religion, sex, age, height, weight, non-disqualifying disability, veteran or marital status.