Description
Fine Chemicals Corporation requires the services of a Quality Control Team Leader for our Quality Control Department.
Requirements
Overview
To manage workflows and plan testing schedules for routine and non-routine analysis on raw materials, in-process, finished goods and equipment cleaning analysis in the Quality Control Laboratory.
The QC Team Leader is required to manage all functions within the team and is responsible for the team’s output.
The Team Leader must ensure that all functions, goals and deadlines are clearly communicated to the team members and ensure that available resources are adequately managed and assigned to meet the QC Lab’s targets and operational needs.
To clearly communicate in a timely manner to all stakeholders to ensure that operations performed in QC do not adversely impact the business needs.
To ensure that the team is adequately trained to carry out their duties according to their job specifications and responsibilities.
Responsibilities
Follow testing deadlines provided by the QC Supervisor in absence and assist in establishing testing deadlines based on business needs.
Plan and strategize to ensure these deadlines are met.
Where relevant, communicate these plans to the Supervisor and/or Quality Control Manager and all other relevant parties if any delays are going to be experienced.
Drive change with all the initiatives being implemented in the QC lab.
Concurrently review sampling and testing operations as well as results generated, any excursions are investigated either via the ATRR, incident or deviation system in the shortest possible timeframe, preferably for sample OOS/OOT this must be done prior to moving on from the current testing system.
Where necessary, ensure that RM’s are released to production as and when needed.
Ensure that during and after testing all the relevant logs and LIMS entries are completed.
During the review of data, ensure that documents in this section are current for the operations to be performed as per the relevant regulatory requirements. Inform Supervisor of changes required.
Establish testing deadlines based on production plan and strategize to ensure deadlines are met.
Communicate any conflicting priorities and delays to QC management and Production.
Review testing operations and result generated, investigate excursions.
Ensure, on completion of tests, the IP and all other logs/ LIMS entries are correctly completed.
Oversee the QC team, ensuring timely task execution and consistent support across departments. Manage daily operations, set performance expectations, and maintain accurate administrative records. Strong leadership is required, adherence to company policies, and a commitment to continuous improvement and quality standards.
Comply with GMP requirements as outlined by Company SOP’s and written instructions on all tasks and activities.
Adhere to all Company OHSE rules and regulations.
Skills required
Background/Experience
National Diploma in Analytical Chemistry/B.Sc. in Chemistry or equivalent or an Equivalent Qualification as per the National Qualifications Framework (NQF) would be considered.
Knowledge of cGMP (current Good Manufacturing Practice) pertaining to the manufacture of Active Pharmaceutical Ingredients (API’s).
Must be competent in using MS Windows software, i.e. Word, Excel, Outlook, Power Point, and Power BI.
Knowledge of LIMS will be integral.
Good practical and theoretical knowledge GLP, ISO 9001 & 17025, Statistical data analysis.
Proven problem-solving skills and techniques.
5 years’ experience working in a pharmaceutical Quality Control laboratory environment at a Senior level.
Additional knowledge of validations, stability testing, R&D is necessary. Some Management experience would be advantageous.
Competencies/Personal Attributes
Good organizational skills, with a hand-on and honest approach.
Good interpersonal skills.
Exceptional attention to detail and accuracy.
Good communication skills (written and verbal).
Excellent report writing skills.
Ability to critically evaluate data and work under pressure.
Plan, lead, allocate and manage departmental activities, resources and tasks in accordance with agreed budgets, service/delivery targets and daily/weekly/monthly plans.
Establish and maintain appropriate systems for operational management and measurement.
Develop and implement continuous improvement plans and actions.
Manage departmental absenteeism.
Apply via company website ( ) or
aspen.mcidirecthire.com
