ProClinical is advertising a vacancy for a Quality Assurance Manager - External Manufacturing Department position with a specialty-
driven biopharmaceutical group at their office in Berkshire. The company, which focuses on innovation and Specialty Care, develops and commercialises innovative medicines in three key therapeutic areas -
Oncology, Neuroscience, and Rare Diseases. Exemplifying this is their growing portfolio, which includes therapies for prostate cancer, neuroendocrine tumours, renal call carcinoma, and pancreatic cancer.
This is an exciting opportunity for an applicant to develop their career an innovative and transformative player in the neuroscience field.
The Quality Assurance (QA) Manager will ensure that the highest standards of Quality Operations (QA&QC) are implemented and maintained at Contract Manufacturing Organisations (CMOs) and Contract Laboratories.
Job Responsibilities :
Deploying and maintaining GxP Quality Management Systems with CMO and Testing Laboratories to ensure compliance with regulations and inspection readiness at all times.
Deploying and maintaining a Quality Auditing capability with use of CAPAs to identify and track required improvements.
Ensuring that critical quality issues are reported to company management using the Global Quality Alert process.
Reviewing and signing-off on master production, process validation, and cleaning validation documentations provided by CMOs.
Carrying out the disposition of Finished Products, APIs, Raw Materials, and Components when required.
Collaborating with the Director of Quality and Director of Relationship Management to develop a quality strategy aligned with the oval business strategy.
Reducing and mitigating product risks.
Developing opportunities for improvement.
Identifying risks associated with company products and systems.
Appropriately remediating and mitigating risks associated with company systems & products.
Identifying and implementing opportunities to simplify EMO business processes, including sampling, testing, and data generation.
Supporting initiatives to meet or exceed Quality objectives.
Contributing to continuous improvement planning and execution.
Contributing to the deployment of the Global Technical & Quality roadmap for External Manufacturing.
Skills and Requirements :
At least a BSc or equivalent in a Life Sciences discipline, chemistry, or biochemical engineering. An MSc is ideal.
Five to seven years of hands-on experience gained in both Quality Assurance and Quality Control departments, ideally with at least three years in a Supervisory position.
Thorough knowledge of cGMP guidelines gained through practice experience of supporting cGMP manufacturing operations.
Extensive experience of Internal & External Quality auditing, CAPA management, deviation management & risk assessments, and preparing for FDA and EMA inspections.
Knowledge of biotech and aseptic manufacturing and processes, along with product testing methods.
Familiarity with LIMS, EQMS (Trackwise), EDMS (Documentum) and EBR (Syncade) or equivalent Quality systems.
Demonstrable multitasking, project management, and execution skills.
Good interpersonal skills, including communication, presentation, persuasion, and influence.
Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
Proficiency in MS Office.