R&D Technical Support Officer
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 the R & D Manager
KEY RESPONSIBILITIES:
- Review and approve the analytical data generated in the R & D Lab. Ensure the data is correct and no deviations made.
- Review and approve the method validation protocols and reports.
- Review and approve the analytical method transfer protocols and reports.
- Review and approve all R&D stability reports ensuring the data is reported accurately
- Perform trending on all the stability data
- Review and approve the COAs
- Review and approve specific reports prepared for the regulatory submission by cross-referring to the raw data.
- Co-ordinate with registration team for responding to the queries from regulatory agencies and customers
- Support R & D team in responding to the queries received from the regulatory agencies.
- Review and approve the working standards preparations and ensure they are used within the shelf life and no deviations made.
- Maintain the log of Dissolution and HPLC and any other instruments’ calibration and ensure that the calibrations are performed as per the schedule. If required address the technical issues.
- Review HPLC data by logging into empower, Lock the channels and ensure GLP is followed.
- Review and approve Bulk hold time study, in-use study and routine stability protocols
- Review the analysts’ logbooks and approve the data.
- Review and approve the deviations/OOS for the Development projects
- Represent the company at the time audits
- Maintain the R & D lab as per GMP requirements
- Back up of data from the HPLC hard drive to a portable drive as per the Data Integrity SOP
- Record number of OOS for the department and report on a monthly basis
- Complete the data review and close the points as per the priorities and timelines discussed with manager
- Report to Manager with monthly issues, the data reviewed and close out points
- Any other activity as per the manager’s instructions
COMPETENCIES:
- Sound knowledge of analytical method development and validation in line with the ICH and GMP requirements
- Hands on experience using HPLC/GC and empower software
- Sound knowledge on the cGLP and cGMP requirements
- Organizational skills, personal efficiency, time management skills and the ability to prioritize competing demands are key communication skills.
- Ability to build relationships and collaborate with others is vital.
- Demonstrate and lead on the values, initiatives and culture of an organization. Professional expertise.
- Positive and proactive person who is energized by having great responsibility
- Practical, action-orientated approach to managing priorities.
- The above is not intended to be construed as an exhaustive list of all responsibilities, duties and skills required.
- Strong computer skills in MS Office
QUALIFICATIONS:
- Degree in Science Discipline or equivalent.
- 3 – 5 years’ experience within the pharmaceutical industry in the relevant field
- Sound knowledge of empower/GMP/GLP
- Strong time management and organisational skills.
PHYSICAL DEMANDS: Health & Safety requirements
Manual Handling Training
WORK ENVIRONMENT:
Office & Laboratory Duties
