Collins McNicholas

Role Responsibilities:

  • Maintains the Wholesale Distribution Authorisation, ensuring compliance with the general conditions detailed, in line with European and local regulations. 
  • Ensure compliance with the requirements of Good Distribution Practice (EU GDP). 
  • Confirm that all aspects of the quality system are implemented and maintained 
  • Ensure initial and continuous training programs are implemented and maintained. 
  • Have oversight of approval for return to saleable stock any medicinal products returned by a customer. 
  • Coordinates and performs recall operations for medicinal products. 
  • To be involved in any decision to quarantine or depose of returned, rejected, recalled or falsified medicinal products. 
  • To approve new customers and suppliers and periodic review of existing customers and suppliers. 
  • Management of customer complaints, ensuring they are dealt with effectively 
  • To escalate any complaints, reported defects, reported falsified medicinal product 
  • The approval of sub-contracted activities which may impact on GDP. 
  • To notify HPRA of any change of RP by way of variation to the Licence. 
  • To manage self-inspections of the facility, ensuring that they are performed at regular intervals following a prearranged programme and necessary corrective actions are put in place 

 

Role Requirements:

Essential:

  • Bachelor’s Degree in a scientific/technical discipline required 
  • A minimum of 3-5 years’ experience in a quality or compliance role within the pharmaceutical industry, most specifically in relation to GMP and GDP. 
  • Formal certified GDP Training on Good Distribution Practice of Medicinal Products for Human Use 
  • Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals. Ability to apply GMP regulations and other FDA and international guidelines to all aspects of the position. Strong Knowledge of regulatory requirements pertaining to GDP. 
  • Demonstrated knowledge and application of industry regulations as they apply to quality, including those of FDA, HPRA, EMEA and other authorities. 

 

Desirable:

  • Experience in auditing of external suppliers, contractors and vendors. 
  • Previous experience working as a Responsible Person

 

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

Firstname (required)

Surname (required)

Your Email (required)

Your mobile (required)

Upload CV (required)

Comment

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