Previous Job
Previous
Quality Manager III
Ref No.: 18-03194
Location: Raritan, New Jersey
Start Date / End Date: 06/04/2018 to 11/16/2018
Description:
Business Quality Manager II

The purpose of this position is to support quality activities for Business Quality including product quality complaints, change control, internal audit/ supplier audits.

1. Process day-to-day product quality complaint (PQC) in Trackwise system including evaluating PQC, assigning investigation, conducting investigation, writing investigation summary. Proactively manage PQCs workflow with stakeholders to ensure all investigations are completed in a timely manner. (25%)

2. Create query and report of PQCs from Trackwise for all products and provide in-depth data analysis of complaint information and trending. Review medical information requests from database and provide in-depth data analysis (25%)

3. Process day-to-day change control records in Trackwise system (25%)

4. Coordinate internal and/or supplier audits including setting up logistic / preparation for the audits, drafting audit plan, supporting audit execution, coordinating audit response and CAPA with stakeholders, creating and documenting audit records in Trackwise system. Ensure all audit commitments are delivered on time (25%)

Qualifications:
Required: BA/BS – Technical / Life Science

At least 4 to 5 years' experience in the Pharmaceutical or related industry;
Up-to-date knowledge of relevant pharmaceutical legislation and GMP/GDP
Experience working in the quality organization

Volume or unit measure of job duties:
20 PQCs / month
15 change control/ month

Equipment usage and abilities needed:
Highly experienced in Trackwise system, generating query and report, and data analysis with Excel spreadsheet
Hours per Day 8
Hours per Week 40
Total Hours 960.00

Attachment :

Contractor, Business Quality

The purpose of this position is to support quality activities for Business Quality including product quality complaints, change control, internal audit/ supplier audits.

1. Process day-to-day product quality complaint (PQC) in Trackwise system including evaluating PQC, assigning investigation, conducting investigation, writing investigation summary. Proactively manage PQCs workflow with stakeholders to ensure all investigations are completed in a timely manner. (25%)


2. Create query and report of PQCs from Trackwise for all products and provide in-depth data analysis of complaint information and trending. Review medical information requests from database and provide in-depth data analysis (25%)


3. Process day-to-day change control records in Trackwise system (25%)

4. Coordinate internal and/or supplier audits including setting up logistic / preparation for the audits, drafting audit plan, supporting audit execution, coordinating audit response and CAPA with stakeholders, creating and documenting audit records in Trackwise system. Ensure all audit commitments are delivered on time (25%)

QUALIFICATIONS
III. Minimum education required for competent performance:
Required: BA/BS – Technical / Life Science
Minimum experience (number of month/years and type of work experience beyond formal education) required for competent performance: 

?=5 years' experience in the Pharmaceutical or related industry; 
Up-to-date knowledge of relevant pharmaceutical legislation and GMP / GDP;
Experience working in the quality organization

IV. Volume or unit measure of job duties: (List the volume of those duties which are repetitive in nature. For example, 75 customer phone calls per day, 20 boxes packed per day, etc.)
- 20 PQCs / month
- 15 change control/ month-

V. Equipment usage and abilities needed:

Highly experienced in Trackwise system, generating query and report, and data analysis with excel spreadsheet