Associate Quality Manager

ConvaTec ,
Rhymney, Gwent
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Overview

Job Description

The Associate Quality Managers role is to ensure compliance of Rhymney site against all applicable regulatory standards. The management of the Rhymney Quality team and responsibility for site leadership in Quality. Also Co-hosting regulatory body audits and owning and maintaining Rhymney validation and risk management procedures; and ensures adherence to procedures.Responsible for maintaining a state of audit readiness by maintaining Quality System records. Duties and Responsibilities + Responsible for the management of the Rhymney quality team and ensuring conformance against all relevant procedures and ISO 13485. + Responsible for the Quality team, actively leading, mentoring and supervising. + Coaching and mentoring quality and other associates at Rhymney + Co-hosts regulatory audits. + Represents Quality on the more complex projects that require coordination of several quality resources. + Responsible for generating and reporting metrics. + Issues validation numbers - Responsible for issuing of validation numbers and maintaining the validation index and tracker + Subject matter expert in validation - Responsible for the assessment of validation requirements associated with changes to the product or process and enforces compliance against validation procedures. + Review and approval of validation documentation. + Subject matter expert in risk management - responsible for the assessment of risk management activities associated with changes to the process or product and enforces compliance with risk management procedures. + Responsible for leading a cross functional team in the creation of PFMEA's and authoring when required. + Actively supports NC and CAPA to ensure timely actions + Develops quality assurance plans by conducting hazard analyses; identifying critical control points and preventive measures; establishing critical limits, monitoring procedures, corrective actions, and verification procedures; monitoring inventories. + Validates quality processes by establishing product specifications and quality attributes; measuring production; documenting evidence; determining operational and performance qualification; writing and updating quality assurance procedures. + Maintenance of site procedures - Responsible for ensuring compliance against relevant regulatory standards and global validation procedures. + Revalidation assessments - Responsible for maintaining compliance with the site revalidation schedule. + Responsible for completing internal and external audits. Education/Experience/Qualifications + Degree, or equivalent, in Science or Engineering + Experience within a Quality management role + Demonstrated people management experience + Demonstrated experience in Pharma/Medtech industry + Regulatory and compliance knowledge of Validation + Knowledge and experience of working with a Quality Management System within Medical Device manufacturing Requirements: + Knowledge of applicable regulations and standards + Knowledge of GMP + Previous experience of managing a team + Knowledge and experience in Non-conformance and CAPA + Knowledge and experience in the Change Control, risk management and validation processes + Knowledge of electronic quality systems; EDMS, CAPA, Change control and MRP + Knowledge and experience of root cause analysis and troubleshooting tools + Excellent Report / presentation writing skills + Strong interpersonal skills + Strong analytical skills + Experience of database and associated reporting skills Desirable but not required: + Software validation + Knowledge of SAP, CEDAR and Trackwise Principal Contacts Internal - Rhymney Site Manager, Rhymney Quality team, AWC Quality Assurance manager, Rhymney engineering and operations team. External - Deeside QC team, Deeside operations team, Material suppliers Travel Requirements Position may involve travel up to 10% of the time, mostly within UK. Most trips will include overnight travel. Language Skills Required + Speaking: Yes English + Writing/Reading: Yes English Working Conditions Working in an office environment and manufacturing environment Special Factors N/A Training requirements: The role holder must be trained as per the individual training requirements appendix attached Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. Additionally, this job description reflects management's assignment of essential functions. It does not prescribe or restrict the tasks that may be assigned. ConvaTec provides equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, gender identity, military or veteran status, genetic predisposing characteristics or any other basis prohibited by law. Not

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