Job Specific Responsibilities

JOB DESCRIPTION
DATE: / August 2016
POSITION: / CS CR Supplier Quality Auditor
BUSINESS UNIT: / Almac Clinical Services
LOCATION: / Craigavon
REPORTING TO: / CS NC Supplier Quality Manager
RESPONSIBLE FOR (PEOPLE): / NA

OVERALL ROLE OBJECTIVE:

The Supplier Quality Auditor is responsible for the vendor management program and all activities related to the evaluation and tracking of vendor performance from a compliance perspective.

JOB SPECIFIC RESPONSIBILITIES:

The post holder will:

1  Assist the Supplier Quality Manager in all activities to ensure that the vendor management program is effectively evaluating and documenting vendor performance. This includes but is not limited to auditing, assisting with supplier related investigations and reviewing/approving supplier TAs

2  Update the Almac Clinical Services Vendor audit schedule, audit documentation and associated tracking tools. Ensure that all vendor information in LiveLink is up to date and accurate. This includes but is not limited to vendor lists , audit schedules, audit reports and vendor responses

3  When required, conduct on-site vendor audits in order to assess the capabilities and potential services that could be provided by third parties. This will involve overseas travel. Conduct the audit and follow up activities in accordance with Almac SOPs

3.1  For new vendors; liaise with appropriate departments to determine the goods or services to be provided and when QA approval is needed. Arrange an audit with the supplier and create a suitable agenda.

3.2  For existing vendors; ensure they are audited biennially in accordance with the procedure for the approval of Almac Clinical Services vendors. Liaise with relevant Almac staff to ascertain status of current performance and business relationship. Review Orion reports and gain an understanding of relevant Quality incidents or Technical Queries relating to the vendor. Pay particular attention to any recurring issues and items that may be of particular interest or a focus point during the audit.

3.3  Generate (where applicable) and authorise audit reports for circulation to Almac Clinical Services Management team and the vendor. Communicate any issues identified where Almac is responsible for CAPAs and track per Almac SOPs

3.4  Evaluate vendor responses to ensure compliance with GMP and Almac standards

3.5  Manage CAPAs resulting from vendor audits and seek feedback at agreed intervals

3.6  Generate and approve Audit Questionnaires

3.7  Liaise with the relevant Departmental Manager and Procurement should a ‘for cause’ audit be necessary. Become knowledgeable in the specific details of current issues.

3.8  Feedback process improvements or Almac deviations or deficiencies that arise during on site vendor audits to the appropriate Almac department

4  Trend vendor performance with input from Purchasing/Procurement and Depot Management and attend vendor performance meetings when deemed necessary

5  Take responsibility for vendor approval in COSMOS and maintain the Approved Vendor List

6  Lead or input into supplier related Quality Incident and Technical Query investigations and change requests. May be involved in the review of vendor investigations reports and responses to Almac quality investigations

7  Assist in the development of both site and Global Policies and Standard Operating Procedures, pertinent to the role

This role may require additional coverage beyond normal working hours and international travel as and when required. It is a condition of your employment that you are able to fulfil this element of the role.

GENERAL ROLE RESPONSIBILITIES:

Quality / Ensure GMP is adhered to in all areas of work.

Health & Safety

/ Understand Company’s Health & Safety Policy and follow all company HSE procedures. Report all accidents or any unsafe conditions in the work place.

Training and Development

/ Ensure training has been received before undertaking specific duties and that all training is recorded in training records.

Human Resource Management

/ Adhere to all HR policies and procedures, to include all absence policies and procedures.

Communication

/ Communicate within your own department to ensure that all relevant information is forwarded to the appropriate personnel on a regular and timely basis. Provide regular updates to your line manager regarding progress on required duties and the status of any projects.

Equal Opportunities

/ Observe and adhere to the company's Equal Opportunities and Dignity at Work policies ensuring that a neutral and harmonious work environment is maintained in which bullying and/or harassment does not occur.

Core Competency Framework

/ Ensure that all job specific responsibilities relating to the overall role objective are carried out in accordance with the requirements outlined within the Almac core competency framework.
By signing this Job Description I accept that I have received and read the Job Description and have accepted the responsibilities identified therein.
EMPLOYEE’S SIGNATURE:
PRINT NAME:
DATE:
This job description should not be regarded as conclusive or definitive. It is a guideline within which the individual jobholder works. It is not intended to be rigid or inflexible and may alter as the Company’s strategic direction changes.

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PERSON SPECIFICATION
DATE: / August 2016
POSITION: / CS CR Supplier Quality Auditor
BUSINESS UNIT: / Almac Clinical Services
LOCATION: / Craigavon
REPORTING TO: / CS NC Supplier Quality Manager
RESPONSIBLE FOR (PEOPLE): / NA
/ ESSENTIAL
REQUIREMENT /

DESIRABLE

REQUIREMENT

/ ASSESSMENT METHOD
QUALIFICATIONS / Degree (or equivalent) qualification / Degree (or equivalent) qualification in a Life Sciences related discipline / Application Form and Documentary Evidence
EXPERIENCE / Previous experience with regulatory requirements within the Pharmaceutical industry / Formal auditing accreditation / Application Form and Interview
KEY SKILLS / Effective communication skills (verbal, written and presentational)
Proven ability to audit in a professional, ethical and objective manner using and interpreting applicable standards or requirements, with an awareness of potential legal and financial ramifications / Application Form and Interview
Proven ability to follow written work instructions
Proven ability to work effectively on own initiative and effectively contribute within a team environment
Ability to organise, plan and prioritise tasks within a high volume, varied workload whilst maintaining a high level of accuracy in all work undertaken / Interview and Psychometric Testing

ALMAC CORE COMPETENCIES
COMPETENCY / BEHAVIOUR /

ASSESSMENT METHOD

RESULTS DELIVERY / Delivers results on time, within constraints and in line with company policy and procedure and organisational strategy. Demonstrates a continuous drive for quality and a commitment to excellence. / Interview
PROACTIVE SOLUTIONS / Analyses and uses experience and logical methods to make sound decisions which solve difficult problems. Seeks practical/workable and innovative methods to deliver solutions. / Interview
LEADS BY EXAMPLE / Promotes a clear vision and mission. Acts as a positive role model for the organisation, fostering a climate of teamwork and development. / Interview
COMMUNICATION / Communicates clearly and effectively. Promotes the exchange of ideas and information across the organisation. Fosters dialogue to ensure everyone understands what is going on. / Interview
CUSTOMER FOCUS / Strives to exceed the expectations and requirements of internal and external customer; acts with customers in mind and values the importance of providing high-quality customer service. / Interview
JOB SPECIFIC KNOWLEDGE / Demonstrates required job knowledge and understanding to successfully and competently fulfill or exceed the requirements of their post. Follows correct procedures and guidelines (SOPs).
Proactively demonstrates a desire to enhance and develop their job knowledge. / Interview

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