Laboratory Analyst

7 days ago

Midrand, South Africa MSD Full time

The Lab Analyst is primarily responsible for the prompt and accurate analyses of bulk products and finished products, environmental sampling and testing of immediate contact packaging components according to our Company’s quality standards, Good Lab Practice and Data Integrity Principles.

Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network dedicated to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.

**Primary Activities**
- Accurate analysis of Finished Products and packing components to ensure they are tested according to our Company's quality standards, regulatory requirements and Good Lab Practice and within the committed lead times.
- Prompt and timeous execution of testing by planning and organising daily workload in order to optimally utilize available time.
- Ensures that Calibrations and Performance maintenance activities are carried out promptly and timeously according to our Company's Standard Operating Procedures and Out of Specifications / Out of Trend results are reported to the Quality Control Lead immediately.
- Takes responsibility for maintenance and operation of the HPLC’S according to relevant Standard Operating Procedures and training provided; assists with troubleshooting.
- Comply with Laboratory housekeeping requirements and Chemical Hygiene Plan guidelines.
- Assess chromatograms for accuracy and acceptability before processing results and reporting abnormal occurrences immediately.
- Evaluates results against release criteria - promptly reports any atypical or u Out of Spec results
- Initiates and coordinate Deviations and root cause analysis for Out of Spec test results
- Adheres to Data Integrity principles
- Initiate Change Controls for the Laboratory
- Implementation, review and training of Lab SOP’s as per regulatory requirements / global Company procedures
- Promptly reports, and where applicable, manages any equipment related issues where unplanned maintenance is required and initiates necessary documentation when required
- Ensures all EHS requirements are implemented and adhered to
- Assists in any remediation required for lab systems compliance
- Participates in method transfer activities including documentation and report writing
- Participates in remediation resulting from all internal and external audits.
- Participates in company training programs to support the company vision as well as any other training to ensure effective fulfilment of duties.
- Implementation of periodic trending of data to determine Out of Trend situations and collaborate to implement corrective actions.
- Participate in activities for the Quality Control Laboratory
- Perform Cleaning Validation
- Perform monthly Environmental Monitoring
- Additional responsibilities include the oversight and management of Quality Control related projects (such as product method transfer, technology enabled global projects for the laboratory); the implementation, sustainment and periodic review of quality management systems and procedures and the trending of data to identify risks and optimisation projects.
- Assists Quality Control Lead in enhancing compliance posture of the Laboratory by assuming responsibility and being accountable for all the primary activities listed below.

**Qualifications/ skills**
- A Tertiary degree in Chemistry or a diploma in Analytical Chemistry (BTech preferable).
- A sound knowledge of analytical and instrumental techniques
- Sound knowledge of HPLC -Empower FR5
- Responsible, accountable and reliable
- Strong investigation and problem solving skills
- Ability to work accurately and efficiently
- Agile and pro-active
- Technical, mechanical and mathematical skills
- Good verbal and written communication skills

**Experience required**
- Minimum 5 years’ experience in a Pharmaceutical environment and Quality Control Environment
- Operation and management of GLIMS (Laboratory Information Management Systems)
- Laboratory related project management an advantage

Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network dedicated to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.

**Who we are**

We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD

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