Study Director (Process Validations)
Norbrook Laboratories is hiring a Study Director (Process Validations) to provide support to the pharmaceutical development team in relation to the transfer of new products to the commercial facility and assist in the lifecycle management of existing products when required.
It is expected that the post holder will be experienced in the field of process validation and be aware of all current guidelines within this field. The post holder must ensure that all work is carried out in accordance with the Company’s Quality Manual, Standard Operating Procedures and H&S requirements.
Main Activities/Tasks
· Provide 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
· Participate in project meetings to discuss project status as required
· 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 (Manufacturing and Packaging Process / Cleaning / Equipment) 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 guidance to help troubleshoot and resolve formulation, manufacturing and analytical issues for commercial products
· 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
· Attend weekly technical meetings with partners to keep projects on schedule and focused on timely completion of established goals.
· To identify and implement process improvements; e.g. yield, cycle time reduction, cost of goods etc.
· 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
· Any other duties as deemed necessary by Management
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
· Excellent knowledge of Microsoft Packages
Desirable Criteria:
· A process / chemical engineering background
· At least two 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.
Duration: Full Time, Permanent
Location: Newry
Additional Information:
· This role will be based in a site that produces and handles penicillin, and as such, this role would not be suitable for those that have a penicillin allergy.
· Applicants should be able to provide proof that they have a right to work in the UK at the time of their application. Applicants who are unable to provide this proof will not be considered.
· We regret that applications received after the closing date and time will not be accepted.
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
Contact: [email protected]
Benefits:
- Canteen
- Company pension
- Discounted or free food
- Free parking
- Health & wellbeing programme
- On-site parking
- Referral programme
- Sick pay
Work Location: In person
