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Compliance Manager


Contact info

Type Permanent
Salary Negotiable
Contact Name Sinead Hawes
Contact Telephone +353 21 4289605
Reference BPSH4787
Category Quality - QA
Location Dublin North

Job info

Description

Berkley Pharma & Life Sciences are currently seeking a Compliance Manager for our multiproduct pharmaceutical client based in North Dublin.

Role/Opportunity:

  • Lead & manage quality specialists and doc clerks
  • Deliver & improve the Quality System
  • Design a system to ensure compliance
  • Maintain Quality System in order to guarantee continuity of the company's manufacturing licence for all markets
  • Identify, lead and implement continuous improvement opportunities for compliance initiatives
  • Responsible for Site Master File process
  • Management of Product Quality Review (PQR) process
  • Supplier Management (incl. complaints handling, analysis of quality performance and certification)
  • Artwork Quality Approval
  • Review & approval of validation and qualification documentation
  • Subsystem ownership and SME input for all relevant subsystems
  • QMS roll out/site coordination
  • Coordination of Significant Investigations
  • Stand in for Head of Quality Operations in his/her absence
  • Focus on Quality policies/strategy in close co-operation with Principle QP and Head of Quality Operations
  • Coordinate significant investigations, in close collaboration with the Principal QP, Head of Quality Operations & Quality Specialists/QP:

         - Identify all necessary actions in preparation of and during the Fact Finding Meeting together with departments, GTO,                     EMEA Quality, Drug Safety, Legal etc

         - Prepare and participate in the Quality Meeting, in which a final decision on actions, possibly to the market, are made

  • Ensure that PQRs are finished on time, and that an integral check/data analysis takes place. Use this information for (continuous) improvement purposes
  • Realize system/process audits
  • Monitor the status of GMP action steps and other relevant performance indicators
  • Create an integral and deep insight in the quality status of the site, in close collaboration with the Head of Quality Operations and the Site Lead Auditor
  • In line with quality procedures and guidelines initiate, support and authorize quality improvements
  • Systemic approach by means of a sub system ownership
  • Focus on continuous improvement
  • Monitor Vendor Quality and liaise with Purchasing
  • Perform Supplier Evaluation
  • Approve Suppliers for use
  • Review supplier certification
  • Review Technical Quality Agreements
  • Handle complaints, including the reporting and response to customers
  • Identify recurring issues
  • Provide support and guidance of GMP training on site
  • Approval all GMP training modules
  • Ensure all GMP training requirements for personnel are met
  • Create an environment and structure that enables staff to achieve preset targets and results
  • Responsible for ensuring team is appropriately trained to complete all tasks
  • Responsible for development of and maintenance of training manual, plans and matrices within the compliance team
  • Develop multiskilled team by use of cross training
  • Coach and mentor staff and assess their performance continually
  • Provide continuous feedback both constructive and positive to team on observed versus expected behaviours (e.g. compliance behaviours, MPS behaviours)
  • Coach and mentor quality specialists to develop problem solving skills
  • Responsible for ensuring compliance with corporate, local and statutory EHS policies and guidelines
  • Create a working environment that makes it possible for the team to comply with all relevant EHS legislation and company requirements
  • Supervise team in EHS compliance and initiate and support improvement in EHS performance
  • Demonstrate personal commitment to EHS policies and guidelines
  • Lead incident investigations, identify true root cause and implement effective corrective actions.


Skills/Experience:

  • Relevant third level degree within a science discipline
  • Additional Qualification in Quality Assurance (Desirable)
  • QP Course (Desirable)
  • Minimum of 5 years experience in a Management position in the Pharmaceutical Industry, knowledge of implementation of Quality Systems.
  • Proven Track Record of successful implementation of Quality management Tools resulting in improved business Processes (Desirable)
  • Deep Problem Solving skills – demonstrated ability in the use of scientific methodology to problem solve
  • Demonstrated ability to fully realize compliance initiatives
  • Knowledge of GMP regulations and ISO Guidelines


Berkley Pharmaceutical and Life Sciences is a specialist recruitment consultancy which recruits pharmaceutical, clinical and medical device professionals throughout Ireland, Asia, UK and Australia


For more information go to http://www.berkley.ie/


To apply: If you would like to discuss this vacancy further or to discuss your career options in confidence, please telephone Sinéad Hawes on +353 (0)1 8724667 or send your CV to pharma@berkley.ie

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