Quality Assurance Manager, Pharma
|Contact Name:||Larry O’Leary|
Our client, a pharmaceutical manufacturer company based in Connaught, now seeks a suitably experienced Quality Assurance Manager to provide effective leadership across the business, contributing to strategic programmes and developing a high performing quality team in an FDA regulated environment.
The scope of this role is wide and varied, with the successful candidate managing the transition of new products from development to commercial manufacture and then Quality oversight of a large Operations area generating significant revenue.
This company has a number of incredibly new innovative products coming through development hence it is preferable candidates will have strong experience in Tech Transfers / NPIs.
This permanent role represents an attractive opportunity for career progression within site and global teams.
Responsibilities for Quality Assurance Manager, Pharma:
Leads the efforts of QA personnel responsible for the monitoring and disposition of the product housed in their manufacturing area in compliance with all regulatory requirements, cGMPs and company policies, procedures and goals.
Leads compliance and Quality improvement efforts in manufacturing with cross-functional participation.
Leads cross functional teams in the execution of Quality processes ensuring a consistent application of principles in the manufacturing area.
Manages and facilitates the reporting process to measure the output and report QA performance metrics and quality issues at manufacturing level.
Provides quality oversight, guidance and direction to Quality team, customer complaints, change controls etc.
Ensure training system is in place to provide appropriate training for all staff.
Recruit personnel to ensure the department is adequately staffed, and develop the group to by facilitating teamwork, job rotation, participative decision making, providing coaching and support by acting as a role model.
Promote and ensure a value driven culture within the Quality Assurance function.
Acts as the QA representative during regulatory agency inspections, and during Corporate audits. Authority to make decisions related to product quality, including the disposition of non-conforming product.
Requirements for Quality Assurance Manager, Pharma:
Bachelors Degree in Science, Engineering or similar technical discipline. Advanced qualifications are desirable.
Qualification / experience in Project Management.
8+ years in QA, Ops or Technical experience in pharmaceutical manufacturing for finished dosage forms or drug product, ideally 2 years of which in a QA Manager role.
Manufacturing related experience in some of the following areas: sterile, stability, solids or APIs.
Project management and troubleshooting skills.
Strong communication & influencing skills, and ability to manage & motivate a team.
Experienced in Quality troubleshooting / tools for fact base decisions making.
Please phone Larry on +353 1-2302400 / email@example.com
The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors. www.rftgroup.ie
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