THE ROLE
As Operational Quality Lead, you will be responsible for ensuring all daily activities related to the release of unlicensed products, batch made unlicensed products and licensed products are successfully completed, staffing levels are maintained as per capacity plan and training is effective. Additional responsibilities include raising, investigating and closure of deviations and customer complaints, CAPAs, change control, risk assessments etc. in relation to the Operational Quality department. This role will also take responsibility for the accountability, storage and disposal of Controlled Drugs.
As an Operational Quality Lead your responsibilities will include, although not limited to:
- To be capable and undertake release of manufactured products in accordance with defined procedures.
- To perform, oversee, approve, and investigate various QMS tasks such as Deviations, CAPAs, Risk Assessment, Change Control, Customer complaints etc. related to Operational Quality activities.
- Ensure all deadlines are achieved for both the release of manufactured products and QMS documentation.
- Be responsible for the accountability of controlled drugs on site including the destruction process and support in the annual returns process.
- To support the Production department, Customer Services and Warehouse department on technical or quality topics as required.
- To support with annual Product Quality Review (PQR).
- To lead and support with the recalls and returns processes.
- To support withs Internal and External Audits as required.
- To support with the process for checking and release of imported products.
- Responsible for the monitoring of regulatory updates along with the amendment of any gaps identified
- To support with the training of staff in operational quality responsibilities.
- To maintain awareness of Pharmacy legislation and requirements that could affect Company’s operations.
- To follow and promote relevant SOPs, Job Aids, Policy and Procedures.
- To actively promote GMP and GDP within the business and provide any relevant training in these areas.
- To investigate new and innovative ways to continuously improve and enhance the department profile and create an environment of learning and development.
- To proactively maintain and develop company Quality and Business Systems in conjunction with other departments.
- To ensure appropriate investigation of discrepancies, errors, complaints, failures, or adverse effect which requires documentation, review, and actions if necessary.
- To comply with GMP, GDP rules and regulations. To ensure that SOPs are read on time.
TO BE SUCCESSFUL IN THIS ROLE, YOU SHOULD BE ABLE TO DEMONSTRATE:
- Scientific degree is highly desired, or a person should have demonstrable good experience in pharmaceutical company or GMP environment.
- Demonstrable track record of skills and experience in Quality Assurance department or in position of similar level.
- Good understanding of pharmaceutical market specially Unlicenced Product.
- Wide knowledge of products and process related to manufacturing of specials.
- Good leadership, communication, and time management skills.
- Good decision-making, self-introspective and analytical, and strategic thinking skills.
- Ability to cope with pressure and change and ‘can do’ attitude.
- Ability to work in fast paced environment and ability to work in multi-cultural working environment.
- Excellent attentions to details and troubleshooting skills.