LOC Quality Executive - PIT Testing at GlaxoSmithkline (GSK)

The role holder is expected to assist the LOC Quality Manager – South Africa in implementing the requirements of the GSK Quality Management System (QMS) relevant to Product Import Testing.

The Quality Executive – PIT Testing has responsibility in the following areas:

• Seamless transition to the alternate PIT 3rd party laboratories facilities
• Maintenance of product specifications and testing methods in alignment with registered details
• Coordination of Analytical Method transfer for any new product introduction to the South African market
• Preparation of Vaccines protocols required by National Control Laboratory for all imported Vaccines prior to release to market
• Receipt and download of temperature monitoring devices for GSK products imported into South Africa (where applicable) & notifying the Product Release Pharmacist LOC Quality or QA Distribution Pharmacist/Manager if this information is not available, or there are deviations from the required transportation temperature
• Coordination with appointed Logistics Service Providers on retention of samples for testing
• Ensuring that test samples are sent to the 3rd party laboratory. and logging the information (Product Name, Part Number, Quantity Received, Lot number and Date received)
• Reviewing 3rd party laboratory results to ensure compliance before final release by Release Pharmacist
• Reviewing and assisting 3rd party labs on laboratory investigations
• Reviewing and approving any related deviation that occurs during testing of GSK products
• Performing any other requested activities related to PIT and release to market.

Scope of Accountability

Provide details of any scope data relevant to the role e.g. the net sales that the role supports / generates or budget responsibility.

Number Of Direct Reports

n/a

Number Of Indirect Reports

n/a

Annual Budget managed by this role: (Provide Revenue/ Assets Managed or Operating budget)

Annual Direct Revenue Accountability, if applicable (add currency)

n/a

Assets Managed, if applicable (add currency)

n/a

Operating Budget Accountability,

if applicable (add currency)

n/a

Knowledge/ Education / Experience Required

• Educational Background List any academic or practical education that must be obtained to be qualified to perform this role.
• Minimum Level of Education

Chemistry degree, diploma

Area of Specialisation

Analytical testing

Why is this Level of Education Required?

Chemistry degree ensures the required technical knowledge to manage the PIT testing programme

• Preferred Level of Education
• Chemistry degree, diploma

Area of Specialisation

• Analytical testing

Why is this Level of Education Preferred?

Chemistry degree ensures the required technical knowledge to manage the PIT testing programme

• Job-Related Experience Describe what experience this position will require the job holder to have obtained in past roles within or outside of GSK that would demonstrate a level of proficiency in the stated role.

Minimum Level Of Job-Related Experience Required

Experience in

• the analytical testing of products.
• laboratory investigations, and resultant CAPA
• review of temperature data related to shipment of imported products

Why is this Level of Experience Required?

To ensure compliant decisions are made regards the PIT testing in order to support compliant supply and protect patients and GSK’s reputation

• Other Job-Related Skills/Background List any licenses, certificates, registrations, or any relevant job skill or abilities not covered in Educational Background or Job-Related Experience sections above that are required for the job.
• Language knowledge (Minimum fluent English)
• Technical understanding of Analytical testing
• Professional experience 5 years+ in analytical testing of products in the pharmaceutical industry

Continuous improvement mindset

Why GSK?

Our values and expectations are at the heart of everything we do and form an important part of our culture.As GSK Focuses On Our Values And Expectations And a Culture Of Innovation, Performance,

And Trust, The Successful Candidate Will Demonstrate The Following Capabilities

These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork.

• Operating at pace and agile decision-making – using evidence and applying judgement to balance pace, rigour and risk.
• Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
• Continuously looking for opportunities to learn, build skills and share learning.
• Sustaining energy and well-being.
• Building strong relationships and collaboration, honest and open conversations.
• Budgeting and cost-consciousness.
• This is a job description to aide in the job posting, but does not include all job evaluation details.