|
|
|
| |
Pharmaceutical, Biotechnology Jobs |
 |
|
|
Search Jobs :
Job Title: Bilingual Sr.QA Operations Manager
Location: Puerto Rico
Discipline: Manufacturing
Reference: CMMQ9658
|
|
Description: syringe filling / ABL manufactured APIs & aseptic processing- filling
sterile drug
product into syringes/clean room env/ managing SVP QA
Operations / Biologics and Parenteral Aseptic Processing.
CMMQ9658
Bilingual Sr.QA Operations Manager
Sterile Laboratories/ Biologist or Chemist
Puerto Rico
Sr. Operations QA Manager is responsible for all quality aspects
associated with the final formulation of manufactured /aseptic
processing / filling of / sterile drug products ( into syringes)
The Sr Operations Manager is responsible for managing operations
including manufacturing quality assurance functions within operations/
approval of manufacturing directions to the production floor/ review &
approval plant investigations/ assess product impact analysis & corrective /
preventive action for events/ review and approval of changes as applicable/
assessing potential regulatory / filing impact
This position is also responsible for managing line clearances, in process
QA
inspections during syringes filling and final Drug Product release/ managing
any investigations related to final Drug Product complaints/
Sr Operations QA Manager interacts closely with the Department to coordinate
general services such as documentation control, batch record review, QC Labs
test, validations, among others/assures that the final Drug Product is
manufactured in compliance with current good manufacturing practices & is in
compliance with EU and local regulations / supports other quality projects
as requested by the Biologics QA Director or the ABL Quality Assurance
Manager, as needed.
Sr. Operations QA Manager interfaces as needed with MS&T, Technical
Support, Engineering, Quality Assurance, QC Labs and Regulatory
from company, and maintains communications at an appropriate level.
Minimum Requirements:
Bachelor's degree in Natural Sciences, Biology,
Chemistry / MS is desirable
*Excellent communication skills in English and Spanish
Qualifications: 12 years of combined experience in the following areas:
Quality Assurance, Compliance and or
Manufacturing; specific to APIs, Biologics
and Parenteral Aseptic Processing. The experience
should include: Technical processes and
troubleshooting exposure, Supervisory experience
managing professionals.
Experience in Management of Small Volume or High
Volume Parenteral operations is a must.
Experience in Formulation and Syringes filling operations.
Highly developed problem solving and analytical skills
Excellent interpersonal skills, including negotiation skills.
Highly developed analytical and statistical skills.
Computer proficient.
Work in a clean room environment
Apply to: Click Here
|
|
|
|
|
