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June 24 2018

    Job details

QUALITY ASSURANCE manager:ICDS Recruitment

Job description:


   » Job ID.:15358868
   » Employer ID.:RI/AM16288
   » Published:14-JUN-2018
   » income:NEGOTIABLE
   » Job location:WICKLOW
   » Employment Type:CONTRACT

 

Quality Assurance manager - County Wicklow.
This position is being offered as a 12 months fixed-term contract.

PURPOSE OF THE POSITION:
Supervise and manage the everyday operations of the Quality Assurance group. Manage site regulatory and cGMP activities and compliance. This compliance to be maintained with the implementation of effective SOPs and systems, validation of test methods equipment and processes, cGMP training programs and effective auditing and self-inspection programs.
Lead and develop QA personnel and to develop Best Practice cGMP systems. Deputise as Quality Manager.

ESSENTIAL JOB FUNCTIONS (key accountabilities):
• Support all site Health, Safety & Environment initiatives and requirements and ensure support of same from reports.
• Assist the Quality Manager in superviseing and managing all Quality Assurance Systems within the facility.
• Investigation reporting including Process Deviation, OOS, Material failures and customer complaints.
• Review and approval of batch related documentation and final product release
• Provide Regulatory and cGMP leadership abilities to all Site and Business Unit Functions
• Provide a QA input to (and manage, as necessary) company validation programmes.
• Ensure the cleaning validation protocol and programs are progressed in conformity with current cGMP norms
• Supervise all Quality Assurance personnel activities and ensure they are carried out in a compliant and timely manner.
• Complete QA audits, inspections and investigations in a timely manner consistent with shipping deadlines.
• Investigate customer complaints and regulatory queries thoroughly, in a timely manner and ensure that all corrective and preventive actions are fully implemented.
• Foster and instill a Continuous Improvement culture within QA and QA related activities.
• Lead and train QA team on detailed Root Cause Analysis investigations related to significant site and product quality requirements.
• Preparation of APRs, DMFs and other recurring cGMP requirements in a timely manner.
• Maintain an updated expertise of current international cGMP trends and cascade this to all reports and to Site leadership abilities.
• supervise the Plant Documentation and Change Control system including drafting of SOP’s, Monographs and Master Batch Records.
• Ensure full Quality group participation in company improvement functions.
• Provide continuous improvement leadership abilities in QA activities to secure process efficiencies and enhancements.
• Act as liaison point with Regulatory agencies as necessary.
• Act as Lead Host in cGMP audits in the absence of the Quality Manager
• Prepare, authorise, manage and ensure delivery of the company cGMP training programme.
• Supervise, recruit and develop QA staff and deal with any staff issues arising in conjunction with Quality Manager and HR.
• Assist in departmental and company goal setting in conformity with Site and Corporate strategic goals, with special emphasis on cGMP goals

QUALIFICATIONS and practice Sought:
Essential: significant Science located 3rd-level qualification with significant regulatory practice

practice/key achievements:
Significant practice at Senior Quality level, in a FDA regulated company.
Broad practice of regulatory and cGMP activities.
Proactive Individual with Change Agent Capabilities. capability to identify, plan and implement improvement activities
expertise/expertise:
Critical: Excellent oral and written communication expertise.
Good attention to detail and good organisational expertise.
Mature judgment, problem solving and decision-making capability.
Essential: Previous managery practice with the capability to operate in a team located environment or proven track record in a similar function.

This job originally appeared on RecruitIreland.com

Skills:

Job Category: Customer Service [ View All Customer Service Jobs ]
Language requirements:
Employment type:
Salary: Unspecified
Degree: Unspecified
Experience (year): Unspecified
Job Location: Wicklow
Company Type Employer
Post Date: 06/14/2018 / Viewed 14 times
Contact Information
Company: ICDS Recruitment


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