Key Roles and Responsibilities:-
Performs laboratory analysis and schedules analysis for a QC team, within a large QC department, that provide DI complaint QC data to support GMP decision making across the Morpeth business, to agreed standards of safety, cGMP, cost and cycle times.
Support the QC Team Manager in the delivery of business commitments;
- Ensuring all materials/products are released in line with business requirements
- Analytical laboratory investigations are resolved, reviewed and approved in a timely manner
- Resource allocations are managed to ensure customer demands are met through liaison with the Supply Chain planners, Project Managers or Technical Services Formulators.
- Maintain QC OTIF in line with customer requirements – support ‘getting tablets to patients’
Provide direct support to the QC Team Manager. Deputise for the QC Team Manager when required.
Ensuring the QC team are supporting business requirements across a 1 month period.
Set work schedules and priorities according to the resource allocated to the team. Escalating any issues or concerns that may impact the delivery of business commitments.
Ensure that all GMP documents; SOPs/DOPs, methods, specifications, protocols etc. are understood and followed by yourself and the QC team. Perform the QC review and approval of all GMP documentation.
Lead out of specification and safety investigations, ensuring investigations are appropriate, root cause identified,appropriate CAPA identified and implemented and the closure is in line with defined timelines.
Manage the effective and timely close out of QMS actions within the QC team, including Trackwise actions.
Provide support to validation activities, including; approval of protocols and reports for analytical methods, manufacturing processes, equipment and cleaning.
Drive the team’s compliance with the agreed and identified metrics. Collect and collate data to support the QC Team Manager’s continual review of performance, efficiency and utilisation of the QC team, in line with the defined metrics / KPIs. Support the QC Optimisation plan in delivery of the identified continuous improvement initiatives. With the QC team, develop new CI initiatives for inclusion in the Optimisation Plan.
Working with the QC Team Manager, support the execution and delivery of individual development plans for the team. Support the training of the QC team and highlight development opportunities.
Quantitative
Ensuring analysis is performed, right first time, on time and in line with business requirements and is performed by suitably trained and experienced analysts.
Support the execution of the site’s monthly finance/sales plan; plan and prioritise the workload of the QC team to ensure delivery of the plan.
Collect and collate performance data.
KPI
Lead QC team to deliver against the metrics.
Support the QC Optimisation plan in delivery of the identified continuous improvement initiatives. With the QC team, develop new CI initiatives for inclusion in the Optimisation Plan.
Qualitative
Ensure QC team working practices are in compliance with cGMP and safety requirements.
Support training and development of the QC team and highlight development opportunities within the department.
Critical Tasks
Ensuring analysis is performed, right first time, on time and in line with business requirements and is performed by suitably trained and experienced analysts and in with cGMP and EHS as required by regulatory and company directives
Set work schedules and priorities according to the resource allocated to the team. Escalating any issues or concerns that may impact the delivery of business commitments.
Collect and collate data to facilitate the management of the performance, efficiency and utilisation of the QC team.
Effective communication relating to QC activities within the business and to external customers
Critical Skills
Excellent planning and organisation skills – for self and others
Effective communicator
Analytical technique expertise
Strong knowledge of cGMP requirements for QC laboratories
Good Manufacturing Practice - GMP
Piramal Healthcare UK Ltd have a responsibility to manufacture medicinal products of the requisite quality, fit for their intended use and be in accordance with the relevant Manufacturing and Marketing Authorisations, Clinical Trial Authorisation, Product Specification, Drug Master File or CEP Dossier as appropriate and which do not place patients at risk due to inadequate safety, quality or efficacy. The Pharmaceutical Quality System, which incorporates Good Manufacturing Practice, is designed to deliver this quality objective, the attainment of which requires the participation and commitment of all staff across departments and at all levels within the company.
Good Manufacturing Practice is the part of Quality Management which ensures that products are consistently produced to the correct quality standards. To comply with the principles of GMP, it is required that clearly defined procedures are adhered to when performing operations across the site.
Health and Safety
As an employer Piramal is responsible for conducting its activities in line with its legal obligations under the Health and Safety at Work Act 1974. It is Piramal’s expectation that all employees observe their individual legal duties under the Act in so far as taking reasonable care of themselves and others who may be affected by their acts or omissions at work, and to cooperate with those persons appointed at Piramal to ensure that any relevant statutory duties are complied with.
It is Piramal’s expectation that all employees are actively engaged in matters related to Health, Safety and Environmental protection and that risk control measures are continuously reviewed and adhered to.
In the three decades of its existence, Piramal Group has pursued a twin strategy of both organic and inorganic growth.
Driven by its core values, Piramal Group steadfastly pursues inclusive growth, while adhering to ethical and values-driven practices.
Equal employment opportunity
Piramal Group is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, ethnicity, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, genetics, or other applicable legally protected characteristics.
We base our employment decisions on merit considering qualifications, skills, performance, and achievements. We endeavor to ensure that all applicants and employees receive equal opportunity in personnel matters, including recruitment, selection, training, placement, promotion, demotion, compensation and benefits, transfers, terminations, and working conditions, including reasonable accommodation for qualified individuals with disabilities as well as individuals with needs related to their religious observance or practice.
