Quality Lead

Key Accountabilities

Quality Lead will be responsible for the following: 

• Subject matter expert to the various lab tasks  

• Lead trainings with personnel to effectively complete tasks as it relates to the Quality Team and Lab Functions.  

• Lab Waste Management with 3rd Party Vendors  

• Lab Inventory Management.  

• Scheduling and Management of: 

• TMYM and OVI Testing 

• Stability Testing  

• Calibration and PMs of Equipment 

• Laboratory Cleaning Schedule 

• ICHQ3D Testing 

• LIMs Subject Matter Expert 

• Production Batch Release Process 

• SOP Updates 

• Assist with Conducting Internal GMP Audits 

• Assist with Work Order, CCP, OPRP PCQI Review and Sign-off 

• Assist with QA Related Training for the facility 

• Back-up and Assist with Lab related Tasks 

• Any other duties or Projects as assigned 

Administrative Support
Provide administrative support in reviewing and monitoring of the QSHE plans and objectives and targets. Provide support in reviewing and monitoring the QSHE Culture. Assist in compliance reviews, general risk assessments and other safety assessments to support Health, Safety and Environmental management. Maintain positive and proactive relations with managers and employees, as well as customers and regulatory agencies. Perform other work related tasks as required as assigned.

Quality Support
Provide quality support: reporting, collecting data, monitoring and reviewing objectives. Facilitate information sharing amongst sites. Administer Management Systems Documents. Assist in quality coordination activities needed to ensure that products meet specification and customer requirements. Where appropriate, provide training and support for site personnel. Assist in audits, inspections, customer complaint investigations and related activities to meet targets and objectives. Produce and manage product information, SDS, etc. QSHE

Compliance
Comply with the

Quality, Safety, Health and Environment
Policies. Be aware and accustomed with the significant quality, safety/health, and environmental (QSHE) aspects/impacts associated with the work, including relevant legal/other requirements and emergency preparedness and response.

Solid line(s) to
QSHE Supervisor

Dotted line(s) to
n/a

Number of direct reports
n/a

Number of total reports
n/a

Number of dotted line(s) reports
n/a

Performance Measures
KPIs agreed in yearly MbO.

Other requirements
Excellent command of both oral and written local language and English are required.Good command of both oral and written additional language is beneficial.

Internal contacts
Supply Chain Management teamsSustainability teamsOperations teams

External contacts
Local communityQSHE associations

Education
High School / Vocational or Associate’s Degree in Occupational, Health & Safety area

Experience
Lab experience within a Food and Pharma environment preferred, or other lab with strong GLP requirements, equivalent education or experience and training may be acceptable as well.  

Knowledge and skills
High level of integrity, excellent team player.Excellent interpersonal skills and understanding of different cultures / work environments.Good organizational skills.Great communication skills both written and verbal.Computer literate, including Microsoft Office.Ability to write clear and concise documentation.Good analytical skills.