Study Director

Main Activities/Tasks

• Technical support to the pharmaceutical development team to aid in both study design/reporting and in problem resolution
• Compile and review protocols, repots, SOPs and Master Plans ensuring that they comply to GMP and safe working practices
• Collaborate with Process Development/Tech Service Team/H&S/Engineering to influence the design and implementation of a robust process control strategy, provide process risk assessments and associated documentation to support equipment qualification activities, PPQ studies and key technical strategies and to provide compliance with the current TT SOP
• Review PCR’s generated for use in the production facility and ensure in line with the proposed manufacturing process as defined by Formulations or Regulatory Submission
• Ensure that Out of Specification and Out of Trend results are fully investigated in line with the company’s SOP’s and Quality Management System
• To maintain an awareness of current guidelines in UK/Ireland, EU, US and ROW in relation to industry best practice for Process Validations activities
• Provide technical support to the regulatory department, where required, on all matters concerning PV studies undertaken by the Pharmaceutical Development Team
• Participate in due diligence initiatives by acting as the subject matter expert for technology evaluation and all types of validation and work with colleagues in relation to validation of Facilities and Computerized Systems.
• Provide technical support to Manufacturing Operations through provision of expertise for investigation and resolution of process deviations, CAPAs, review and approval of change controls associated with New product introduction
• Provide technical input and evaluation for GMP Investigations from the manufacturing facility
• Oversee with hands-on involvement in batch manufacturing for development, pre-approval, engineering and pre-market commercial scale batches
• Ensure compliance with EHS policy, cGMP and other business regulations and participate in risk assessments, audits and incident investigations
• Ongoing technical support of Manufacturing Operations by providing technical expertise for investigation and resolution of process deviations, CAPAs, review and approval of change controls

Essential Criteria:

• A degree in a scientific discipline
• Previous experience working in a cGMP environment.
• Working knowledge of VICH guidelines.
• Practical working knowledge of process validation.
• Experience in the compilation of protocols, reports and interpretation of raw data

Desirable Criteria:

• A process / chemical engineering background
• 2+ years' experience in a cGMP environment.
• Previous relevant experience in Process Validation and scale-up within a pharmaceutical company.
• Previous practical experience of scale-up from development to routine manufacture.
• Experience in scale-up of various pharmaceutical dosage forms.

Benefits:

Free life assurance
Company pension scheme
Healthcare cash plan
32 days annual leave
Wedding leave
Company sick pay
Employee well-being initiatives
Employee assistance programme
On-site free parking
Subsidised canteen facilities
WeCare programme – supporting the local community
Employee perks scheme
Employee recognition scheme
Career development opportunities