Job Description

JOB DESCRIPTION:

We are seeking a highly motivated individual to join us as a Quality Assurance Supervisor/Manager. This individual will have the responsibility for Quality aspects related to Quality Systems in the Printing and packaging facility.

The Quality Assurance Manager will ensure compliance with current Good Manufacturing Practices (cGMP) as they pertain to the local regulation and exporting countries regulation as applicable.

OVERALL RESPONSIBILITIES FOR QUALITY OPERATIONS AND INITIATIVES, INCLUDING

1)      Quality Assurance management

2)      Documentation control and management (master batch record, specification and method)

3)      Batch record review and product disposition

4)      Investigations, complaints, deviations, CAPAs

5)      Production and Pharmaceutical Development support

6)      GMP training and SOP review

7)      Validation / qualification documentation review and approval

QA OPERATIONS:

Inspection, sampling, and review of incoming materials, perform customer inspections support and drive compliance throughout the site

Develop, maintain, and enhance training programs and systems

Driving key compliance initiatives such as, Training Program Enhancements, Quality Documentation System Enhancements, other identified initiatives. Must be able to move about the facility

Experience with customer Audits

Extensive knowledge of US and EU current Good Manufacturing Practices

IN COLLABORATION WITH THE QUALITY ASSURANCE TEAM, THE QUALITY ASSURANCE MANAGER WILL BE RESPONSIBLE FOR:

 i)  Quality Compliance management:

 ii) All audits, internal, external - regulatory, client and vendor

iii). Vendor management program

 iv) QA Agreements with clients & contractors

 v) License renewals

 QUALIFICATIONS

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  Position requires a high degree of self-motivation and good organizational skills.  Depending upon prior experience up to 2 months of training are required to properly prepare a person for this position.

EDUCATION AND/OR EXPERIENCE

Associate degree or equivalent from two-year college or technical school; or six months to one-year related experience and/or training; or equivalent combination of education and experience.

LANGUAGE SKILLS

Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals.  Ability to write routine reports and correspondence.  Ability to speak effectively before groups of customers or employees of organization

REASONING ABILITY

Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form.  Ability to deal with problems involving several concrete variables in standardized situations.

PHYSICAL DEMANDS 

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 regularly required to stand; walk; use hands to finger, handle, or feel; and talk or hear.  The employee frequently is required 

to reach with hands and arms.  The employee must occasionally lift and/or move up to 35 pounds.  Specific vision abilities required by this job include close vision, and ability to adjust focus.

 WORK ENVIRONMENT 

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually moderate.

Company Description

Thank you for taking the time to learn more about our company. Medlit Graphics is the fastest growing company in pharmaceutical printing. A full-service supplier providing a variety of products and services to meet all of pharmaceutical packaging needs. Operated by a pharma experienced group, we understand business from the perspective of a drug maker which allows to ensure every detail of our process keeps in compliance.