|Role Type||Fixed Term Contract|
Validation Compliance Specialist
Job ID: JOB-11911
Validation Compliance Specialist
Provide expert QA Validation support to facility, equipment, process and software teams in parallel to the establishment of the Pharmaceutical Quality System. Ensure compliance to relevant regulations and objectives are achieved for the plant. This Quality Engineer will play a key part in establishing and leading validation compliance by engaging and working with a cross functional team to ensure adequate procedures and processes in place to consistently meet Pharmaceutical guidelines requirements.
- Work in conjunction with Engineering Departments to co-develop facility and equipment design verification & validation protocols, review and approve protocols/studies, and perform general oversight responsibilities for the validation process (facility, equipment, processes and software).
- Pre and post approval of qualification and validation protocols, reports, and associated data for conformance to associated regulations and acceptance criteria. Also ensuring the effectiveness of such documents in achieving site compliance in a focused and concise manner. Documents including but not limited to:
- Qualification of facility, equipment and utilities.
- Computer system validation.
- Laboratory equipment validation.
- Process validation.
- Cleaning validation.
- Site validation plans.
- Annual Reports.
- Ensure Regulatory compliance in area of responsibility (Annex 11/15) for GMP pharmaceutical regulatory agencies (FDA, HPRA etc.)
- To review and evaluate URS/FS/ FAT/SAT documents and reports to ensure a good design basis is established for all validation studies
- Generate, review or execution of VMP/DQ/FQ/IQ/OQ/PQ protocols/reports for equipment, facility, utility, process & computerised systems.
- Ability to translate local, corporate and regulatory requirements into validation requirements
- Resolve both GMP and business issues and deviations
- Coordinating and performing validation activities, tracking and reporting the progress of activities, anticipating and removing obstacles to progress
- Identification and implementation of appropriate statistical techniques to monitor process performance.
- Transfer and implement processes from development or from another manufacturing facility.
- Support a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulations
- Assist with risk assessments/change controls and deviations by providing input as a subject matter expert on behalf of validation
- Provide mentorship and SME knowledge in the area of validation (process, cleaning and utilities) and across all levels at the site, ensuring compliance with current industry regulations, guidelines and trends.
- Presenting executed qualifications during internal and external audits.
- Perform gap analysis on the site procedures for areas of responsibility against current regulations and corporate policies and adapt site policies/SOP’s to comply with latest regulatory and corporate expectations.
- Excellent interpersonal, leadership, communication (written and verbal) and time-management skills are essential.
- Excellent trouble-shooting and problem-solving skills
- Ability to think logically and be proactive
- 5 + years’ experience working with validation and qualification projects within GMP regulated environments.
- Excellent understanding and hands-on working knowledge of cGMP, quality and regulatory requirements for all aspects of medicinal product Validation, with experience of the regulatory inspection processes.
- Previous experience in a Quality, or Manufacturing background, particularly in relation to pharmaceutical quality systems
- Level 8 qualification in Engineering or related technical/Quality discipline.
- Excellent written and verbal communication skills
- Demonstrated ability to work with cross functional organizations in a dynamic manufacturing environment to solve problems
- LEAN and Six Sigma philosophy are embedded in your day to day working.
- Travel may be required as part of the role when safe to do so, for example to attend FAT’s.
- Full understanding of cGMP requirements including Annex 11 and Annex 15
- Experience in the pharmaceutical industry and GMP manufacturing
- Working knowledge and understanding of FDA, HPRA, and the pharmaceutical industry quality requirements and associated with manufacturing controls.
- Experience in problem solving and process improvement methodologies
- Process Validation, Risk Management, CAPA experience.
For further information on this Validation Compliance Specialist role in Cork please contact Emma Griffin on firstname.lastname@example.org/0860334325
Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/ Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval
Apply Now Job ID: JOB-11974 IT Systems Administrator My pharma client based in County Galway are looking to hire an…
Apply Now Job ID: JOB-11973 Regulatory Affairs Specialist Permanent Job Purpose: As a Regulatory Affairs Specialist, you will be a…
Apply Now Job ID: JOB-11861 Staff Lean/Continuous Improvement Engineer Our client, is recruiting for a Staff Lean/Continuous Improvement Engineer to…