Advertise
|
Tell a Friend
|
About
|
Contact Us
|
Home
Find Jobs
Post Resume
Company Profiles
Career Resources
Vendors
Employers & Recruiters
Home
>> View Job
Career Tools
Get a Job Winning Resume
What's Your Former Boss Say About You?
Blast Your Resume
Free Magazines
Find Job Fairs
My Network
Find Training Courses
Pharma Talk Blog
Find Service Providers
Featured Jobs
Healthcare Jobs
Strategic Procurement Advisor, Global Supply Chain - Arlington VA
Management Sciences for Health
Pharmaceutical Jobs
Director, Sr. Product Manager - Patient
Sucampo Pharmaceuticals, Inc
Healthcare Jobs
Apply online for the Manager, PCQA Ops position and advance your career in the Pharmaceutical industry today.
Manager, PCQA Ops : GlaxoSmithKline
Job Number
73171
Employee Type
Full Time
Company Name
GlaxoSmithKline
Location
Collegeville
Pennsylvania
Salary (year)
Experience
2 to 5 Years
Start Date
1/27/2012
Industry
Pharmaceutical
Job Type
Quality-Assurance
Relocation
Not Required
View all jobs from GlaxoSmithKline
Apply Online
What Does Your Boss Say About You?
Description
Basic Qualification
B.S degree in appropriate science related discipline
Minimum 5 years relevant experience in quality assurance or a quality-focused role
Broad knowledge of the R&D drug development process/pharmaceutical industry.
In-depth knowledge of GMPs, EU Regulations and a thorough understanding of quality systems
Knowledge of primary and secondary manufacturing processes and facilities and equipment validation
Demonstrated experience leading a team and/or managing personnel
Proven ability to understand and consider broader risks beyond compliance
Demonstrated ability to communicate with clarity and impact
Strong interpersonal skills and effective negotiating skills
Proven ability to interact with peers, subordinate and senior personnel in multidisciplinary environment.
Proven ability to prioritize and decide appropriate course of actions
Details
Promote and maintain a high level of GMP awareness and compliance within Investigational Material Supply and Product Development
Provide general QA support and consultancy to primary and secondary manufacturing operations.
Support validation of equipment and facility
Release active pharmaceutical ingredients and drug products.
Conduct internal Assessments
Assist in the implementation of the PCQA Ops strategic plans to facilitate day to day operations.
Lead process improvements initiatives
Actively develop and manage direct reports
Manage multiple projects of demanding high priority including regulatory inspections and high risk non-compliance issues.
Manage resources, priorities, schedules and/or projects to assure delivery of team objectives.
Interpret and communicate changes in the regulatory environment that could impact GSK to proactively mitigate and resolve potential compliance issues.
Work independently and engage- with the business in strategic and/or operational decisions on behalf of the team.
Requirements
Preferred Qualification
Experience with root cause analysis and managing Quality Investigations
Experience identifying and mitigating quality risks
Experience as a Lead Auditor
Experience with batch release of active pharmaceutical ingredients and drug products
Experience in the validation of facilities and equipment
OE Green Belt
Contact Info
Apply online at company website
Find More
Pharmaceutical Jobs
in the Pharmaceutical industry.