Overall Purpose of the Position:
To assist in the implementation of the TASK Quality Management System (QMS) comprising of a QA Manual and a Site Quality Manual. The Clinical Quality Assurance Manager references the QA Manual for day to day operations and ensures that the Site Quality Manual (SQM) is implemented by all sites.
Key Performance Areas (KPA’s) & Responsibilities includes, but not limited to:
- Attending IM and/or SIV to ensure a thorough knowledge and understanding of study protocols and expected procedures and requirements in order to identify the possible need for Standard Operating Procedures (SOP) and / or staff training or to implement systems.
- Reading and analysing protocols and manuals
- Drafting and maintaining the QA Manual, audit tools and Site Quality Manual (SQM)
- Conducting an Annual Review of the QA Manual and SQM to analyse the implementation and efficiency of quality and inspection systems and tools and discussing with QA Head (QAH) for final approval and roll out.
- Assisting QAH in drafting TASK Standard Operating Procedures (SOP’s) and Policies as required as well as study specific SOP’s / Policies when requested.
- Ensuring SOP’s/Policies stay current by assisting QAH in reviewing and updating SOP’s within three years after approval date or as processes change or new information becomes available. Manage SOP distribution system and training on them.
- Assisting in identify training needs, implement, coordinate via internal or external programs and maintaining clinical training modules and records to ensure current records for training of staff to proof qualification (non-protocol specific) and competency as per job description and delegated tasks.
- Assisting to coordinate and schedule / oversee clinical relevant equipment services when needed and coordinate annual calibration of all clinical equipment by maintaining a system to control, replace, receive and distribute equipment and calibration certificates between sites and maintain an equipment inventory list per site and TASK overall.
- Sharing the workload across the team, offering support to ensure that QA key indicators are monitored and trends are identified and reported. Ensuring regular feedback on overall QA/QC status of TASK to QA Head.
- Managing the QA feedback at Friday meetings
- Preparing six-monthly QA progress reports as per study requirements and communicating outcome to QA Head and feed back to sites, sponsors, company directors.
- Assisting in planning and conducting internal audits on protocols, systems, procedures and other QA and QC activities and document outcome, analyse data to identify areas for improvement.
- Investigating and overseeing customer / sponsor complaints and non-compliance issues and reporting to QA Head
- Assisting sites in audit preparations, coordinate and support site during external audits.
- Evaluating audit findings and implement appropriate corrective and preventative actions (CAPA)
- Providing professional guidance to team members with complex issues.
- Assisting in drafting clarifying MEMO’s when needed by QAC and ensure record keeping thereof as well as record of any general QA findings.
- Ensuring QA job descriptions are current and implemented by doing performance appraisals if needed.
- Contributing to hiring decisions, when required.
- Performing miscellaneous job-related duties as assigned.
- Bachelors or BSc degree preferred
- Three to four years’ experience in a management role within related pharmaceutical industry or Clinical Research Organisation would be an advantage / One to three years’ working experience as CRA preferable
- Demonstrated experience in implementing quality assurance systems and assessing processes and identifying needs within clinical trials.
- Knowledge of current GCP guidelines and regulations, including ICH guidance and other regulatory requirements regarding clinical documents. Valid GCP certificate.
- Strong computer skills including Microsoft Office, Word and Excel, PowerPoint
- Knowledge of tools, concepts and methodologies of QA in clinical trials
Key Personal Inherent Characteristics
- Internal motivation, take initiative, a proactive attitude
- Judgement calls and decision making
- Attention to detail
- Excellent communication skills – verbal and written (report writing), presentation skills
- Data collection, management and analysis thereof
- Problem analysis and problem solving, planning and organizing
- Flexibility and continuous learning
APPLICATIONS CLOSE:4 July 2019
Please use the following reference when applying for this position: CQAM
If you have not heard from us within one month, please consider your application as unsuccessful.
Task Applied Science reserves the right to withdraw this advertisement and not fill the above mentioned vacancy at any stage during the recruitment process.
Contract type: Permanent