Senior Microbiologist

KEY DUTIES AND RESPONSIBILITIES

Accountable for improving quality, compliance and embracing good quality culture within the laboratories. Working with commitment with the Pharmaceutical Quality System that is in place by following procedures and maintaining the integrity all laboratory data at all times.

* To routinely test raw materials, finished Products, Stability Samples and Investigational Samples using microbiological techniques (PET, TAMC/TYMC).

* Purified Water testing and Growth promotion test for media using in-house procedures.

* To routinely perform environmental monitoring for clean room.

* To perform microbiological test implementation of new compounds: method development, validation and documentation.

* To perform cleaning validation by using swab/contact technique.

* To test as per assigned target dates and report results to GMP standards as per company SOPs and guidelines

* To write reports, SOPs and other documentation when required including Monitoring and trending of microbiological data.

* Maintain laboratories to a high GMP / Visually organized and professional standard by assisting in general housekeeping of test areas.

* Support, engage with and implement continuous improvements in QC department.

* Support, engage with and implement continuous improvement projects in QC Micro department and collaborate with other departments for site projects.

* Continuously improve the overall department productivity and efficiency in order to meet KPI’s and business needs.

* Managing and approving QC Micro team consumables needs as per budget and in a cost considerate way.

* Ensuring robust training programmes within the laboratory, as well as the review of SOPs, investigations, specifications, methods and reports.

* Championing change and implementing new processes and procedures.

* Managing and completing QMS actions in a timely manner as per KPI target dates.

* Involvement in internal and external QC audits and also proactively maintaining the laboratory in an audit ready state.

* Responsibility for QC compliance in accordance with GMP (GQCLP).

* Leading OOS investigations using formal root cause analysis tools and methodologies to assure informed decisions are based on sound scientific objective evidence.

ESSENTIAL EXPERIENCE, SKILLS AND ABILITIES

* Relevant degree in a scientific discipline

* Minimum 5-7 years’ experience of working in a pharmaceutical Quality department in clean room.

* An understanding of GMP

* Excellent time management and organization skills

* Excellent verbal and written communication skills

* Experience working in a laboratory environment is desirable

* Proficient in the use of Microsoft Office including Word and Excel