R&D Administrator

Galway

About Chanelle Pharma:

Chanelle Pharma is Ireland’s largest indigenous generic pharmaceutical manufacturer of both medical and veterinary products.

Serving customers in 96 countries worldwide, Chanelle Pharma is a partner of choice in the development and manufacturing of pharmaceutical products to the world’s leading human generic and animal health multinationals and distributors. We are passionate about understanding and addressing the challenges facing our medical and veterinary customers and bringing them innovative and effective products and solutions. 

The Opportunity:

This is an opportunity to be part of a dynamic team within the R&D function. We are looking for individuals who will support and drive Chanelle Pharma’s vision to be the most valued global provider of high quality, competitively priced pharmaceutical products and to provide excellent services and support to our customers.

In this role you will report into R&D Manager.

KEY RESPONSIBILITIES:

• Set up DS codes and AML packs in co-ordination with sourcing and procurement for new Materials/Packaging materials for R&D.
• Prepare of OTPs/MWOs/PWOs/FCWOs/PVPs/Stability protocols/in-use study protocols/hold time study protocols for optimisation and pilot batches of various dosage forms in discussion with the formulators or managers.
• Work closely with Quality, QA Regulatory and Production to ensure that production Work Orders targets are met through open communications and teamwork.
• Initiate, complete and close out of Change Controls through Quality System (Q – pulse) for new or update production documents, e.g. Forms, COI, STM, Manufacturing Work Order and Packaging Work Order and Deviations for R&D department.
• Coordinate with Planning regarding Manufacturing slot schedule on weekly basis.
• Issue Log book numbers for new and Control R&D documents and Log books.
• Raise Purchase Orders for R&D through Softco or relevant software system.
• Coordinate material/packing request to Warehouse for R&D requirements.
• Organise and arrange shipment of samples and relevant documents for stability and testing to Jordan Labs.
• Coordinate training to R&D team for new and updated procedures.
• Coordinate samples for external testing including Micro, PET, XRD and any others.
• Review completed work orders for filling.
• Support for the preparation of Tech Pack for regulatory submission.
• Maintain the stocks of Reference products for R&D.
• R&D trial PWOs and co-ordinating with production planning for packing the R&D trials.
• Set up regular meetings as per managers’ instructions.
• Any other activity as per the manager’s instructions

COMPETENCIES:
• Organisational skills, personal efficiency, time management skills and the ability to prioritise competing demands are key communication skills.
• Experience working in pharmaceutical manufacturing environment.
• Systems experience desirable.
• Excellent attention to detail.
• Ability to build relationships and collaborate with others is vital.
• Demonstrate and lead on the values, initiatives and culture of an organisation. Professional expertise.
• Positive and proactive person who is energised by having great responsibility.
• Practical, action-orientated approach to managing priorities.            • Strong computer skills in MS Office.
• The above is not intended to be construed as an exhaustive list of all responsibilities, duties and skills required.

QUALIFICATIONS:
• Graduate in science or commerce.
• Working experience in a GMP Laboratory or QA/ Compliance Environment is a distinct advantage.
• Excellent written and communication skills.

PHYSICAL DEMANDS:                                                                                                                                                                                         • Health & Safety requirements.                                                                                                                                                                     • Manual Handling Training.

WORK ENVIRONMENT:
• Office & Laboratory Duties

R&D Administrator

Galway