Supervisor, Quality Operations

Summary:
Under the direction of the Manager, Quality Assurance, the Quality Operations Supervisor is responsible for supervision of the Quality Assurance Operations Department staff.

The Lead Quality Operations Supervisor is accountable for all reviews and releases of job orders; production quality gates, initiation, review and approval of item-related non-conformance reports and Change control requests.

The Quality Operations Supervisor must act as a Quality Consultant to Production Operations, being a key point of contact between all departments to promote fitness of the systems and processes employed in their area of responsibility, providing technical oversight and serve as escalation point where support and intervention is required within the company, to generate reliable, accurate and complete data.

The Quality Operations Supervisor is expected to possess or obtain sufficient knowledge to provide input or approval of proposed changes to GMP systems during which will interface closely with other cross-functional groups such as Manufacturing, Packaging, Maintenance, Product and Process Development and Warehousing.

**Responsibilities**:

- Supervisory:

- Support the reportees completing their assigned tasks and coordinate work load to effectively provide quality oversight for each production shift.
- Ensure staffing is appropriately assigned to cover operational needs.
- Determine and assess performance metrics of each reportee, as well as performance metrics of the department as a whole.
- Ensure that KPI performance goals and developmental plans are documented for each reportees and that they are review biannually.
- Provide coaching, mentoring and constructive feedback and empowering reportees.
- Communicate to reportees in an open, balanced and objective manner.
- Participate in the recruitment of qualified staff for the department.
- Production Quality Oversight:

- Supervision and control of the quality assurance aspects of sampling, manufacture and packaging including review and documentation thereof.
- Provide quality consultation to resolve any lot related issues identified by the production department.
- Assists and support in the assessment of any non-conformances identified, ensure they are escalated to management and closed off within the target timeline.
- Monitor GMP/SOP Compliance for the facility and remind all staff of the importance of following SOPs.
- Lot Review and Releases:

- Ensure all lots are reviewed, dispositioned and system (M2M) transactions for product approval/rejection are conducted accurately and in-line with operational needs, any non-conformances are documented, investigated and closed within target timeframe
- Ensures release documentation for customers (Certificate of Analysis, Certificate of Manufacture and Certificate of Packaging) are compiled and provided.
- Liaise with internal and external customers, as required.
- Operational Document Reviews:

- Ensure Data Integrity Reviews are conducted and discrepancies reported in a timeous manner.
- Ensure that all logbooks are reviewed and discrepancies reported in a timeous manner.
- Review and approval of New Item Request Forms for the initiation of production required documentation.
- Ensure that Environmental Alarms are attended to, reviewed and assessments conducted
- Sample Management:

- Ensure retain samples are managed as per procedure.
- Product Reworks:

- Ensure that the Rework of non-conforming lots are assessed, approved and coordinated.
- Feedback to Operations:

- Participate and provide appropriate feedback in the daily direction setting meetings or other meetings as required.
- Metrics and Reports:

- Compile, assess and trend departmental performance metrics to identify trends, escalate and set up corrective/preventive actions if required.
- Project Management:

- Recommend, manage, champion as well as delegate Continual Improvement Projects identified in the department to increase efficiencies and performance of systems.
- Participate in cross-functional teams on process control, improvement, and optimization projects; as well as participate in other continuous improvement projects.
- Training:

- Provide on-going training to department staff.
- Ensure all reportee training is completed on time and up to date.
- Audits:

- Participate in internal, external as well as Regulatory audits.
- Performs other related duties as assigned.

**Experience**:

- Minimum 5 year work experience in the Food, Pharmaceutical or Medical Device Industry.
- Minimum 3 years’ experience in a GMP regulated environment and in a quality assurance or manufacturing function.
- Minimum 2 years hands on experience working experience in production environment
- Minimum 2 years supervisory or leadership experience

Education, Certification, Licenses & Registrations:

- Educated to a degree level (technology, science, pharmacy or other health related discipline) e.g. B.Sc. or equivalent combination of education and experienc