Peer Reviewer (30 months)

Job description

Details:
Job Purpose:
Provides proficient and supports technical investigations/monitoring and peer review of analytical data, utilising a range of analytical techniques including chromatography, pharmacopoeial and physical property tests.

Scope:
The role directs corporate compliance by the interpretation of corporate standards, pharmacopoeial requirements, regulatory authority directives and commitments made to regulatory authorities relevant to the Site, and other GSK companies or third party contractors in respect to the testing of materials and products

Quality Responsibilities:
Read and understand all relevant Quality Management System documents and Operating Procedures relevant to your job role.
Perform duties in a compliant manner and behave in accordance with our Quality Management System requirements to ensure cGMP standards are maintained.
Participate fully in our quality initiatives and attend training and complete assessments as required.

EHS Responsibilities:
Read and understand the EHS Systems documents and Operating Procedures relevant to your job role.
Ensure risk assessments, risk communication and action planning are completed in accordance with our Risk Management System (RMS).
Ensure that all incidents and accidents are reported to determine root cause and that any subsequent CAPA's are closed out in a timely manner.
- Lead by example to demonstrate the right EHS behaviours and encourage others to improve our safety culture.

Essential Job Responsibilities//Accountabilities:
• Prepares and checks analytical data accurately according to company, customer and regulatory requirements and site procedures.
• Reviews ,Verifies the quality and accuracy of analytical results and determines if material meets pre-defined acceptance criteria.
• Takes a lead role in batch/job approval process.
• Is responsible for the safety of self and others within the laboratories
• Ensures own work is right the first time (RFT). Shares best practices to aid others in improving RFT performance

Customer:
• Ensures analytical records are accurate, clearly laid-out, legible, and recorded at the time of the task.
• Communicates progress on tasks and may provide updates on project progress to team or cross-functional meetings
• Approves batches/jobs, ensuring all documentation is complete, accurate and the material is suitable for intended use
• Undertakes complex analytical tasks, such as the planning, execution and reporting of analytical studies.

Compliance:
• Able to follow and have a detailed understanding of the specifications for sample analysis and be able to use Pharmacopoeias proficiently.
• Checks analytical data/worksheets for accuracy and compliance and ensures correct methodology has been used.
• Ensures training is provided where required.
• Ensures that own training records are kept up to date to meet regulatory and company requirements.
• Documentation is completed at all times accurately, clearly and in accordance with GMP requirements
• Attends training courses and lectures that support the laboratory role.
• To carry out Level 1 audits and support Level 2 audits, when required
• Follow and apply principals of Data Integrity

Continuous Improvement:
• Train, coach and mentor other team members. Act as a positive role model
• Facilitates and promotes continuous improvement initiatives.
• Encourages team to contribute ideas to new ways of working to improve systems in the laboratory.
• Is required, to be involved in various audits and provide responses to auditors questions for Level 1,2,3 and 4 audits. Will lead internal audits. Completes all audit actions within agreed timelines
• Seeks best practice and shares within the team and to a wider audience
• Maintains continual on the job training for self and others
• Maintains a development plan for self and others
• Helps, encourages others to increase their skill base.

*LI-GSK

Contact information:
You may apply for this position online by selecting the Apply now button.

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Preference will be given to candidates in line with the GSK SA and GSK Consumer Healthcare Equity Plan.

jobDetails

Desired profile

Basic qualifications:
School: Grade 12

Post School:
Graduate qualification (or equivalent experience) in a scientific discipline.
B-Sc , Diploma in Analytical Chemistry or equivalent

Experience:
Pharmaceutical or related scientific discipline
A minimum of 3 years experience working in a Chemistry Laboratory in a pharmaceutical manufacturing environment.
A minimum of 3 years experience in validation of analytical methods for routine testing and cleaning.
Experience in operating HPLC and GC at least 3 years.

Preferred qualifications: