The Senior QC Analyst shall carry out most of his / her duties in the Quality Control Laboratory and the primary tasks and responsibilities of the position are as follows.
- Working as directed by Laboratory Management according to Company safety policies, cGMP and cGLP.
- Formulating weekly work schedules with the Laboratory Management and ensuring that these schedules are communicated and followed.
- Checking raw materials, in-process and finished product work.
- Trending of raw materials, in-process, finished product results.
- Ensuring results are recorded in a timely and accurate fashion.
- Reviewing analyst documentation and ensuring Right First Time KPIs are achieved.
- Issuing monthly / annual reports to the Laboratory Management
- Ensuring that all Quality Systems within the department are adhered to on a daily basis.
- Trouble-shooting within the QC Department and providing technical assistance / support to other Departments within the company.
- Maintaining laboratory SOPs and specifications in a state of compliance.
- Assisting with out of specification investigations and Unplanned Deviations.
- Training of QC staff and regular review of training records.
Applications must possess the following knowledge, skills, qualifications and experience.
- At least 6 years’ experience working within a cGLP environment (HPRA and FDA approved).
- People management experience of 1-2 yrs. within a lab environment with a proven track record of effectively scheduling & delegating Analysts' work.
- A BSc in a related discipline is a must.
- Extensive experience with HPLC, IC & GC is required (Desired Level: Subject Matter Expert)
- Ability to critically review analytical data. Possessing excellent attention to detail is a must.
- Ability to advise, lead and manage a small team of analysts.
- Ability to trouble shoot, identify analytical issues and follow up with corrective actions.
- Experience of preparing for regulatory audits.
- Prior experience of implementing training modules
- Our company is a privately owned pharmaceutical group with an extensive portfolio of marketed cancer care products and a robust drug development pipeline.
- Our mission is to bring respect, integrity and quality to our products, services, and all that we do to improve the health and quality of life in every person affected by cancer
- HBP operates a state-of-the-art drug product development and manufacturing facility for the production of oral, solid and topical dosage forms.
- In addition, the company carries out final packaging of special dosage forms such as sterile forms and soft gel which are produced by its worldwide network of CMOs. HBP also acts as the Group's supply chain platform, distributing the Group's products globally.