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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