Title: Principal Engineer - 1st Shift - Onsite

Mandatory skills:

EMA, FDA
Six Sigma
Compliance management system
Manufacturing operations
cGMP

Description:

Compliance Engineer

JOB SUMMARY:

Schedules, plans, and coordinates compliance audits and quality systems assessments ensuring compliance with corporate and regulatory provisions of the Quality System.
Conducts internal audits and compliance gap analysis using the applicable quality manuals, global and/or local procedures, applicable country regulations, directives, standards, inspection guidelines and compendia as requirements.
Supports management during external inspections and participates in the preparation, coordination, and management of external inspections as required.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Other duties may be assigned:

Work with internal auditors to develop programs to ensure continued compliance with policies and regulations.
Support internal audit process ensuring compliance with all applicable regulations and standards.
Evaluate quality data and determine strategies, actions, and initiatives to drive improvements in the facility. Work with cross functional teams on implementation.
Apply continuous improvement methods such as lean manufacturing to enhance manufacturing quality, reliability, or cost-effectiveness.
Evaluates corrective and preventive action responses to the audit findings for adequacy, including root cause determination and timeliness. Escalates issues to management as appropriate. Tracks and reports on commitment status through closure.
Manages the audit file through the entire process to closure. Prepares summary reports depicting results and trends for management review purposes.
Performs follow-up audits, when applicable, to confirm corrective and preventive action is effective.

Qualifications:

Knowledge of cGMP and global regulatory guidelines such as EMA, FDA, and other health agencies.
Knowledge of Six Sigma methodology and LEAN principles.
Effective communicator at all levels; excellent written, oral, and interpersonal communication and presentation skills
Experience with pharmaceutical and/or device quality and compliance management systems, desired.
Hands-on experience in drug product aseptic manufacturing operations is desired, but not required.

Education and Experience

At least 5 years of directly related experience within the pharmaceutical industry or medical device experience
BS in Science or Engineering. Advanced degree a plus.
Project management experience, preferred.
Previous experience with due diligence, auditing, compliance management or regulatory experience is a plus.

Note:

Shift - 1

VIVA USA is an equal opportunity employer and is committed to maintaining a professional working environment that is free from discrimination and unlawful harassment. The Management, contractors, and staff of VIVA USA shall respect others without regard to race, sex, religion, age, color, creed, national or ethnic origin, physical, mental or sensory disability, marital status, sexual orientation, or status as a Vietnam-era, recently separated veteran, Active war time or campaign badge veteran, Armed forces service medal veteran, or disabled veteran. Please contact us at for any complaints, comments and suggestions.

Contact Details :

Account co-ordinator: Godwin Deepak A, Phone No: Extn : 359, Email:

VIVA USA INC.
3601 Algonquin Road, Suite 425
Rolling Meadows, IL 60008
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