Collins McNicholas

Role Responsibilities:

Ensure that internal and external quality standards are adhered to (cGMP/Regulatory requirements) for commercial product:

  • Approve all operational procedures/instructions specification & master production instruction with the potential to affect the quality of the product.
  • Review and approve of validation protocol & reports, study protocol & reports to support Capital or key site projects as required
  • Making sure that there is stability data to support retest or expiry date, storage conditions
  • Support inspections and audits from external parties (e.g. FDA, IMB, EMEA or alliance partners).
  • Participating in internal audits as required
  • Participate in the preparation/review of regulatory dossiers.
  • Establish and maintain support and key liaison representative with Third Party Managers
  • Oversee key quality systems such as (CAPA /ER report system, Change Review Board system etc.)

Managing the QA Operations Team:

  • Allocating the work of the department to ensure schedule adherence in alignment with site KPI’s and shipping schedules
  • Participating in the recruitment of new employees.
  • Completing the Annual Appraisals of QA operations staff and ensuring stretch goals, and appropriate learning and development goals for each
  • Partaking of department budget management

Ensuring the Release or rejection of batches of (including oversight of QP to perform the following:

  • Manufactured bulk or finished products or purchased finished products in compliance with the cGMPs and licence requirements.
  • By reviewing:

        –  Production files

        –  Analytical files

        –  Origin of raw materials

        –  And all appropriate documentation

  • By establishing a system to release or reject raw materials, intermediates, packaging, labelling materials and finished product.
  • By making sure critical deviations are investigated and resolved
  • By setting up a performance indicator to monitor adherence to release schedules
  • By dispositioning of discrepancy reports.
  • Ensuring appropriate CAPA’s are in place.

To meet Internal & External cGMP Requirements:

  • Preparation and Approval of Annual Product Review (data collection, graphic analysis…)
  • By participating to the review and updating of the regulatory filing (US & European, DMF type 1), with the collaboration of the regulatory department.
  • By reviewing and assessment of GMP critical systems
  • Participating and follow-up the audits and/or inspections carried out at the site by the authorities or clients.
  • Participate in technical and scientific meetings, in training days, trade fairs, conferences. Provide to operations all guidelines and documents.

Participate in the development of the Quality department and the quality standard across the site:

  • Participate in the generation of initiatives and action plans for the development of QA operations and improvement of GMP compliance across the site.
  • Participate in the achieving of QA objectives and quality plans.
  • Participate and follow-up of audits and/or inspections carried out at the site by the authorities or clients

 

Role Requirements:

  • Relevant 3rd level qualification
  • Enrol or have completed education to meet the requirements for position of Qualified Person as defined in Article 49 Directive 2001/82/EC
  • Demonstrated ability in the leadership, management and development of a team in a pharmaceutical area
  • Previous management / supervisory experience essential
  • Experience of GMP auditing and documentation.
  • Excellent communication and presentation skills

For a confidential discussion and more information on the role, please contact Josh Barnes on 021-4911066 or email josh.barnes@collinsmcnicholas.ie

First Name

Surname

Your Email (required)

Your mobile (required)

Preferred Collins McNicholas Office (required)

Comment / Cover Letter

Upload CV

In order to provide you with our services, we need to process certain personal information about you. We will only use your personal information to deliver the job-seeking or related services you have requested.

We seek your consent to store your data and provide you with the best possible service. If you have any questions regarding our legal obligations to you or your rights under the GDPR please refer to our privacy statement which clearly outlines all of your rights.

Related Articles

5 Brilliant Benefits of Temping!

Benefits of Temporary Contracts Blog
Accepting temporary contracts can be an excellent way of earning an income. Whether you are on holidays from college or ‘in between jobs’, there are plenty of benefits to temping:   CV Regardless of how long a contract is, all jobs bring new and fresh experiences to your CV. Temping is a great way to upskill […]
Read More

Biopharma Report

biopharma biopharmaceuticals industry report
Ensuring that the supply of qualified professionals is sufficient to meet demand will be the crucial step in successfully expanding the biopharma industry in Ireland. The EGFSN (Expert Group on Future Skills Needs) estimates that 5,000 additional staff will be employed in biologics manufacturing by 2020. The number of professionals employed in the production of traditional […]
Read More
  • Find a job
  • Apply
  • Get a job