Job Description
This consultant will be expected to oversee the work of 10 analysts/scientists with the majority of these being late twenties/early thirties in age so quite a young team. The Client would like to see at least 2-3 years supervision experience and between 7-10 years' experience in total.
Responsibilities
- QC Bioassays Team management, motivating employees towards achieving of the set objectives
- Approval of specifications, sampling instructions, test methods and other biological procedures in Quality Control department
- Preparation, review and approval of protocols, reports, methods, procedures, instructions and other Quality Control documents
- Ensuring the performance of all necessary biological analysis and evaluation of records
- Timely and reliable performance of analyses
- Responsibility for Certificates of Analyses
- Ensuring performance of appropriate validation of pharmacopeial methods
- Ensuring maintenance and qualification of premises and equipment in the department
- Providing introductory and other trainings according to employees' needs
- Participation in internal and external audits
- Performing all the duties according to current GMP requirements and other pharmaceutical regulations
- Selection of and cooperation with contract laboratories
- Supervision of the quality records
- Preparation of the annual budget of Quality Control Bioassay based on production plans
- Planning of subordinate employees' work and progress reporting
Requirements
- ELISA/QPCR/Cell Based Assays
- GMP
- QC experience
- QC Supervision/Team Lead experience/Manager
- Method Transfer
- Method Validation
- Bio Method experience
- Stability
- Motivator/Teacher/Hands on/driver/approachable
