MENU
   
Welcome!! Register or Login
February 17 2018

    Job details

Offer: Microbiology Senior Analyst:Alexion Pharmaceuticals

Job description:

Microbiology Senior Analyst

Alexion Pharmaceuticals


   » Roscommon
   » See description
   » Temporary full-time
   » Updated 09/02/2018
   » HR this job is expired SaveSave Apply Now

Job detail


The QC Microbiology Senior Analyst will support the QC department in Athlone
 

Position Summary
The QC Microbiology Senior Analyst will support the QC department in Athlone with emphasis on technical support with regard to facility testing oversight, test method validation and new technology.
this function will be responsible as an SME on product testing and environmental monitoring with responsibility for deviation writing, technical writing and schedule management for the shift team in Athlone.

Principal Responsibilities
The prosperous candidate will be responsible for:
   » Ensuring high cGMP, GLP standards are maintained and adherence to schedules and targets to meet regulatory and business requirements.
   » Validation/Qualification of Microbiology test methods and test systems such as the Endotoxin test system and Identification system.
   » Collaborate with the QC System Specialist to develop and implement LIMS for the Microbiology Laboratory.
   » Lead and participate Quality Risk Assessments relating to the Microbiology.
   » Maintain regulatory compliance through the creation and maintenance of programs for laboratory testing, training, SOPs and validation. Preparation of documentation for audits carried out by internal auditors and Regulatory bodies.
   » Represent the Microbiology department in internal and external audits where appropriate.
   » Close out of actions/ recommendations identified from both internal and external audits.
   » Assist in ensuring that current compliance issues and trends, both internal and site-wide, are critically evaluated and training is provided where appropriate.

Qualifications
   » Minimum of 7 years of practice in cGMP Quality environment.
   » practice in testing of sterile drug product and aseptic filling process of sterile pharmaceutical /biopharmaceutical products.
   » Good expertise of current regulatory requirements for Microbiology / Sterility Assurance in support of cGMP operations supporting clinical and commercial manufacturing.
   » Subject Matter Expert in Method Validation, Endotoxin testing and sterility testing
   » practice in Quality Risk Management.
   » Excellent expertise of LIMS and practice in the setting up and implementation of LIMS for Microbiology.

Education
   » Degree in Microbiology or related science.

Competencies
Success in the function is dependent on demonstrating the following competencies:
   » A high degree of technical competency in Sterility Assurance, Aseptic filling and microbiology methods.
   » capability to develop collaborative relationships with other functions and sites in order to achieve functional, site and company goals.
   » Excellent problem solving and root cause analysis expertise.
   » Routinely takes an innovative approach in developing processes and procedures that are both efficient and compliant.
   » Strong organizational expertise.
   » Planning/scheduling of own work and subordinates and capability to delegate tasks where appropriate.
   » Excellent written and oral communication expertise.

As a leading employer in our industry, Alexion is proud to offer a highly competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness and financial security of our employees and their families. Benefits include group medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To lgain more about Alexion, please visit www.alexionpharma.com or download our App for iPhones and Blackberries.
Ref: 11281
Apply Now
Report This Job

 

Alexion Pharmaceuticals


   »
5 reviews

 


   » Alexion International Trading, College Business & Technology Park, Blanchardstown, Dublin 15
   » +353 (0) 1 254 6400
   » http://www.alexionpharma.com



Skills:

Job Category: Customer Service [ View All Customer Service Jobs ]
Language requirements:
Employment type:
Salary: Unspecified
Degree: Unspecified
Experience (year): Unspecified
Job Location: Roscommon
Company Type Employer
Post Date: 02/09/2018 / Viewed 9 times
Contact Information
Company: Alexion Pharmaceuticals


Apply Online