Pharmaceutical Chemistry & Compliance Manager
Major pharmaceutical company based in Hampshire
GMP/GLP R&D role for a pharmaceutical analyst/chemist with a keen interest in Regulatory Operations, Stability, CMC, Standards, SOPs, eCTD Submissions.
A key new role with my favourite client a leading pharmaceutical company located in the M3/M4 area. I'm looking for someone who has expertise in monitoring standards, defining process and managing inspection readiness and compliance across bioanalytical, pre clinical, Phase I and CMC submission management.
My ideal candidate will have a combination of expertise across the GLP/GMP functions, someone who has been functioning at an operational level and is now ready for leading compliance initiatives alongside provision of technical expertise when needed. There is scope to mentor and train staff and contractors, also to lead inspection preparation and lead best practice in this exciting global organisation.
You'll be accountable for compliance and training of Non-Clinical Development staff and helping to ensure Pharmaceutical Sciences, Biosciences, Exploratory and Discovery disciplines are compliant with the R&D and corporate policies and procedures. In addition, the Manager represents NCD dept. on SOP review committees, compliance and training meetings. The position assists in the development and implementation of departmental, global R&D processes, procedures for GMP/GCP/GLP/HSE compliance as well as corporate policies^and maintaining operational efficiencies. The Manager assists with coordination of department's involvement in GMP/GCP/GLP/PV MHRA and FDA inspections and internal audits but maintains oversight of departmental vendor inspections by our clients QA and regulatory authorities. The Manager may also support the Pharmaceutical Sciences team with analytics and stability data management for the development of global products: and contributes to management of the regulatory submission process; to deliver the highest quality global submission-ready standard CMC components of regulatory submissions in eCTD format and to agreed timelines and maintain dept. electronic document management system, compliant with GMP.
Essential Skills & Qualifications Required
Bachelor's in Chemistry or Pharmaceutical Sciences
Project management experience in the Pharmaceutical Industry
Experience in writing/reviewing test methods, validation reports and stability protocols
Familiarity with regulatory guidelines and experience in regulatory submissions (CMC Module 3 information and QOS documents)
Experience of compliance/training/inspection/audit and familiarity with MHRA/FDA inspection requirements.
Effective management of the electronic document management system.
Excellent interpersonal, communication, analytical, and organisational skills.
Strong knowledge of Windows environment and Windows-based desktop productivity applications including Adobe Acrobat Technology, Electronic Documentum Management as well as advanced Microsoft Word capabilities.
Knowledge of FDA and EU requirements for analytical testing of drug substances and product.
Expertise in analytical methods
Software Competence Required MS WORD, EXCEL, Powerpoint, Adobe Acrobat, Documentum
Employer: Pharmaceutical Company
Employment Type: Permanent
Hours: Full time
Location: Office Based near the M3
Plan Start Date: Negotiable
Our client will consider supporting relocation and offers^a generous package of employment benefits.
Chemistry, pharmaceutical , sciences, Registration, Regulatory Affairs, MAA, CMC, GMP, GCP, GLP, HSE Expert Reports, CPMP, Dossier, bioanalytical, eCTD, stability,Regulatory Agency, Documentum, Adobe, contractor, CMC, analytical, vendor, CRO selection, Contracts, Clinical Trial Agreements, Quality Assurance, Audit, Inspection, CAPA, Findings, CQA, SOP, Auditor, GMP Inspection, Audit
Assigned Consultant: Ann Maloney, Managing Partner^at CSL on 01932 234689. Please feel free to call for a detailed Job Description or additional information
Applications are reviewed within 24hrs, applicants will only receive feedback if they are suited to the role. The role may have been remarketed; if you applied for this role previously and were unsuccessful you will not receive a response. We are unable to respond to applicants who are not EU nationals unless they include evidence of right to work in full time employment with their application. Do apply with relevant information on required location or salary/day rate if you are a new candidate.