This range is provided by RT.Lane. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base pay range
R.T. Lane Recruitment are currently recruiting for a QA Specialist for Validation and New Product Introduction to work with a Pharmaceutical Company in Carlow.
This is an 11-month contract with strong potential for extension.
**Please note that candidates must hold the correct working visa for Ireland as my client cannot offer visa assistance and must be already residing in Ireland**
** Please note due to a high volume of applicants you will only be contacted if suitable for the position. **
Responsibilities:
* In this role, you will play a vital role in supporting the introduction of new products.
* Quality oversight of executed validation completed at the facility.
* Management and the development & manufacture of vaccines and biological products.
* Alongside your day-to-day QA activities, your main focuses will be reviewing and approving all Validation documents relating to a sterile facility including cleaning validation ensuring to support corporate compliance and regulatory expectations for manufacturing.
* You will report to the Associate Director of Quality and collaborate closely with cross-functional teams on-site, particularly Technical Engineering.
* Your key objective will be to ensure that manufacturing, technical, and regulatory requirements are met.
* The successful candidate will have experience in Quality oversight experience particularly in reviewing and approving documents associated with Equipment Validation, Cleaning validation, Sterilization such as Autoclaves and other equipment like CTU's, Isolators etc.
* Also looking for Quality oversight of equipment Qualification and knowing how to review and approve the following documents IQ, OQ, PQ, IOC, IOQ's etc.
What skills you will need:
To excel in this role, you will also require the following:
* A bachelor’s degree or higher in a related Science discipline.
* A minimum of 3-5 years of experience in a quality role, ideally in a pharmaceutical manufacturing environment.
* Knowledge of regulatory/code requirements related to Irish, European, and International Codes, Standards, and Practices.
* Familiarity with cGMP (current Good Manufacturing Practice) and GDP (Good Distribution Practice).
* Strong report, standards, and policy writing skills.
* Experience with equipment and process validation.
* Familiarity with sterile filling processes and equipment.
* Proficiency in Microsoft Office and job-related computer applications.
* Experience or familiarity with Lean Six Sigma methodology.
* Good collaboration skills and the ability to work effectively as part of a team to determine priorities.
* Demonstrated ability to work independently and take ownership of improvement initiatives with a moderate level of guidance.
* Proven ability to drive the completion of tasks.
* Strong decision-making capability with a sense of accountability and responsibility.
* Demonstrated problem-solving skills.
For more information or a full Job Description please contact – Michelle Power, R.T. Lane Recruitment on 022 46969, 087 032 8195 or email michelle@rtlanerecruitment.ie
Seniority level
Mid-Senior level
Employment type
Contract
Job function
Analyst, Production, and Quality Assurance
Industries
Manufacturing
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