Address
Form of workActiv Pharmaceuticals, based in Smeaton Grange, manufactures liquid and cream products in cosmetic and therapeutic grades and is a part of the Activ Pharmaceuticals Group.
We are now looking to hire a Senior Quality Control Chemist to join our dynamic team.
Essential Criteria are as follows:
- Expert in HPLC method development and full analytical validation as per ICH guidelines with the ability to prepare documented development plans and validation protocols, as well as preparing final validation report for regulatory submission.
- Experience in the use of Compendia (BP, USP etc).
- Be proficient in the use of HPLC equipment, including troubleshooting.
- Experience in working in a GLP/GMP environment and understanding the Code of GMP and its application to the lab environment.
- Experience in performing lab equipment calibration.
- Understanding ICH guidelines on stability testing with experience in stability program management, preparing stability protocols and performing stability testing.
- Min. 5yrs experience in a cGMP lab.
- Min. 3yrs experience in HPLC development and validation with liquids and creams preferred.
- Min. B.S. Chemistry or closely related field.
Duties of this position will include:
- Performing investigations and root cause analysis for both routine testing as well as for the analytical method development projects.
- Providing technical support to Management (e.g., summarised QC data, trend records etc).
- Providing analytical support to the product development department.
- Maintenance of QC records, including notebooks and logbooks in accordance with GLP/GMP requirements.
- Reviewing Supplier/Manufacturer CoAs, supply chain records and other QC documentation
- Performing analysis and formal release on starting materials, including packaging, finished bulk and finished product as required and in a timely manner
- Providing training to new lab personnel.
The successful candidate should also possess the following:
- Excellent communication skills
- Ability to work independently or as part of a team
- Have a sound understanding of data integrity requirements in the laboratory
In return, Activ Pharmaceuticals will offer:
- An immediate start working a 38 hour week with a 2.30pm finish on a Friday
- Competitive salary
- On site parking
- The support of a professional team working in a safe environment
