Job Description & Person Specification
JOB DESCRIPTION
Job Title: Compliance Officer
Department: Quality, Technical & Compliance
Reports to: Technical Manager
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MAIN PURPOSE OF THE ROLE
▪ Collate & Review pharmaceutical product batch files for timely release by Responsible Person (RP) or certification by Qualified Person (QP).
▪ Provide timely Quality reviews for Secondary packaging lines in 2 different sites.
▪ Provide timely Quality reviews for Primary packaging lines at a specific site.
▪ Raise in a timely manner on request or using own initiative Third party notification, CAPA, Deviation and Change Control.
▪ Monitor alerts for potential overdues for Complaints, CAPA, Deviation and Change Control.
▪ Please note that a full, valid UK driving licence is required for this role, as travel between 2 sites 4.2 miles will be routinely required.
KEY RESPONSIBILITIES
▪ Assist in the Pharmaceutical Quality Management of all Waymade, Sovereign Medical, Medifast International and Atnahs products.
▪ Assist in the generation and maintenance of procedural and controlled documentation.
▪ Responsible for maintaining logs of existing Technical Agreements with contract manufacturing organisations (CMO).
▪ Undertake both Primary and Secondary packaging line Quality start up and in process checks.
▪ Report issues which may impact on product release in the first instance to Technical Manager (in absence to either Qualified Person and/or Head of Quality).
▪ Collate and review batch paperwork for manufacturing, packing and QC testing prior to the certification/release of the product by a QP/RP.
▪ Generate summary reports for Stability Results.
▪ Generate summary reports for Annual Product Quality Review.
▪ Complete facilitation or assigned tasks in relation to the following Pharmaceutical Quality Systems:
• Department Risk Assessments
• Training Effectiveness Reviews
• Root Cause Analysis
▪ Other duties as assigned, at the discretion of Line Manager.
KEY ACCOUNTABILITIES
▪ Demonstrate flexibility and willingness to assist and ability to work in a team environment
▪ To be punctual, polite and courteous
▪ Ability to work on own initiative
▪ Good communication skills
Compliance Officer
| |Requirement |Essential |Desirable |
|Qualifications |
| |A level Grade B/C in Biology and or Chemistry |√ | |
| |IT literate in Microsoft Software Packages, particularly Word, Excel and |√ | |
| |Outlook | | |
| |Pharmaceutical Sciences graduate |√ | |
| |Knowledge of Sage ERP (Waymade Stock Control Programme) | |√ |
|Experience & Competencies |
| |Previous experience working in a similar role within a Pharmaceutical |√ | |
| |environment | | |
| |Strong attention to detail |√ | |
| |Able to work flexibly and under own initiative |√ | |
| |Full, valid UK driving licence |√ | |
|Knowledge & Skills |
| |Excellent communication, both written and oral |√ | |
| |Excellent working knowledge of Current Good Manufacturing Practice. |√ | |
| |Time management Skills |√ | |
| |Ability to work under pressure |√ | |
|Personal Qualities |
| |Enthusiastic and highly motivated |√ | |
| |Positive attitude and flexible approach to work. |√ | |
| |Self starting and able to work on own initiative |√ | |
| |Reliable and punctual |√ | |
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I have read and understood the above job description
|Signed | |
|Print Name |Date |
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