Laboratory Analytical Scientist

2 weeks ago

East London, South Africa Aspen Pharma Group Full time

**Overview**
- Lead scientific investigations in QC Lab
- Develop systems and processes for conducting investigations within GMP requirements
- Evaluate analytical equipment and techniques
- Reduce on Laboratory OOS with effective Preventative Actions
- Improve efficiency by reducing repeats
- Trend and analyse OOS data to identify improvements

**Responsibilities**

**Planning and Operational Support**
- Provide technical and operational input on operational planning of the unit and on the prioritisation of objectives
- Determine, request and allocate assets and resources for fulfilment of work objectives, and monitor its use
- Analyse concepts and suggest streamlined procedures
- Identify training needs of QC staff

**Deviations Investigations**
- Lead all scientific investigations within the QC Lab
- Lead the identification, investigation and reporting of OOSs, deviations, and other nonconformities according to GMP requirement and SOPs
- Identify OOS data trends to establish any systematic issues in process, testing, calibration or maintenance
- Implement plans to reduce and mitigate OOSs
- Perform impact and risk assessments of CAPA plans on process compliance

**Reporting and Record-Keeping**
- Compile complex reports and documents according to GMP requirements
- Update records and systems as required
- Ensure that recordkeeping complies with legal requirements
- Monitor and control access to databases in area of responsibility

**Skills Required**:
**Background/experience**
- Post Graduate Degree/ Diploma in Chemistry/ Analytical Chemistry with 2 to 4 years’ related experience
- Experience in quantitative and instrumental analysis in QC laboratory environment

**Specific job skills**
- Extensive experience in scientific principles and laboratory techniques and methodologies
- Scientific report writing skills
- Understanding of pharmaceutical manufacturing, standards and compliance requirements
- Ability to interpret and implement policies, processes and objectives

**Competencies**
- Information Gathering
- Interrogating Information
- Offering Insights

**Accountability & Decision Rights**
- Exercise interpersonal, communication, training and problem-solving skills to optimise team performance
- Integrate resources for an area
- Escalate highly complex problems or out-of-policy issues

**Decisions relating to**:

- Technical approach for project components, often in ambiguous situations, requiring advanced analytical skill, training and/ or education
- Establishing own work priorities and timelines
- Interpretation of policies, standards, requirements and approaches

**Deliverables**
- Deviations, OOSs and other nonconformities investigated and reported
- Laboratory OOS reduced
- Investigations performed according to regulation and standards
- All deviations reported
- Plans implemented to address, reduce and mitigate deficiencies
- Record-keeping complies with legal requirements
- Data integrity and access to systems controlled

**Innovation, Creativity & Problem solving**
- Identify and lead opportunities to enhance staff productivity and operational processes, tools and services
- Demonstrates creativity and initiative to problem solve and improve results
- Regularly contribute actionable ideas

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