Job title: Quality Manager
Industry: Pharmaceutical / Packaging
- Driving a compliant work environment, leading a high performing team to deliver against defined business goals, objectives and key performance indicators.
- Maintains the Sites Quality Management System in line with the relevant Standards and Regulations e.g. ISO 9001 and ISO 15378.
- Ensure compliance to the Corporate quality management systems, policies, procedures and protocols.
- Enhance customer relationships by improving quality performance across key indicators.
- Drive and embed a preventive action culture via root cause investigation, risk assessments in collaboration with Operations.
- Provide leadership for the site in regards to customer and / or product requirements.
Essential Duties and Responsibilities:
- The job holder is aware of all relevant procedures as per company policy that pertain to the position covered by this job description.
- Establishes the duties and responsibilities of subordinate staff and prepares concise job descriptions.
- Regularly assesses the performance of subordinate personnel. Gives counselling and training as appropriate to ensure that existing employees are worthy of promotion when opportunities arise. Act as a coach and mentor to reporting staff and colleagues.
- Host the site Quality Management Review in line with agreed frequency, ensure action follow-up and timely close out.
- Defines audit plans for QA-process and internal audits for the plant, ensure schedule compliance and sufficiently trained auditors are available to perform audit.
- Responsibility for the data gathering and reporting of Annual Product Reviews, as required.
- Supporting data gathering for regulatory submission, as required
- Takes all appropriate actions to achieve results according to the agreed KPIs and agreed personal goals.
- Identify and drive quality improvement projects to reduce the number of CAPAs arising within the business
- Ensure capability of hosting of third-party audits, ensuring general audit readiness throughout the business.
- Responsible for the quality data trending e.g. CAPA, OOS, Deviations, Customer Complaints and Change Requests and driving quality improvements across the site.
- Interface with customers to ensure concerns/complaints are communicated and effective corrective and preventive actions are implemented in a timely manner.
- Assist the plant to meet customer expectations and support problem solving efforts
- GMP Training preparation and execution as required including GMP Induction Program, Annual GMP Training (site and supplier) and Training in QMS processes as required.
- Prepares monthly QA statistics and reports to Senior Director Quality Ops, including the coordination of necessary activities to drive improvements or address adverse trends
- Final Batch release decision, including responsibility for the execution and final disposition of IPC and incoming testing as well as trending of this data.
- Ensure sufficient quality support and competencies are in place to support /network projects to ensure flawless transition into Operations e.g. tech transfer. In particular, ensure alignment with sending sites in terms of inspection plants, defect categorisation including, when required, defect libraries.
- Responsibility to accept or reject suspect raw material and auxiliary material.
- Audits suppliers and supports issues of delivery specifications for raw materials and auxiliary materials in co-operation with Quality Systems.
- Manage a system for sufficient document and retain sample storage, archiving, retrieval and destruction
- Input to the development and preparation of the budget and ensure close follow up during the year
- Responsibility for the approval of change controls, qualification of new equipment and/or validation of new processes.
- Interface with sister sites with respect to sharing of best practices and harmonisation / standardisation of company procedures and practices.
- Performs other duties as assigned based on business needs.
- Conforms with and abides by all laws, regulations, policies, work procedures, instructions, and all safety rules.
- Exhibits regular, reliable, punctual and predictable attendance
- Master diploma with scientific background
- Minimum 4 years of experience in Quality role
Preferred Knowledge, Skills and Abilities:
- cGMP, ISO 9001, ISO 15378
- Green belt training
- Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description
- Support and contribute in Lean Sigma programs and activities towards delivery of the set target
- Able to comply with the company’s safety policy at all times
- Able to comply with the company’s quality policy at all times.
Duration: Permanent role.