Project Support Associate

Job content

RenaClinical is a dynamic pharmaceutical company specialising in the manufacture, importation, warehousing & distribution of commercial and clinical trial medicines across the UK and rest of the world. RenaClinical has invested significantly to expand their UK & Irish manufacturing capabilities to include large-scale tablet & capsule manufacture, tablet coating and blistering of tablets & capsules.

RenaClinical is recruiting into the Projects Team to support the continued business growth and manufacturing demand. Previous experience in Project Management is desirable but not essential as significant GMP and Project Management training will be provided for the ideal candidates.

JOB SUMMARY:

· Assisting in the coordination of set up and close out of specific projects, as assigned.

· Working with colleagues to schedule project work, accounting for deadlines, available resource and business need.

· Where available, use of appropriate project planning tools e.g. Asana to track and communicate milestones and critical path activities and responsibilities.

· Liaising with and providing feedback to Project Managers.

· Preparation of reports and other key information.

· Pro-active communication with all internal and external stakeholders

· Communicating with and providing support to assigned clients

· Participation in client and internal meetings, where appropriate.

MAIN DUTIES AND RESPONSIBILITIES

This job description outlines the current main responsibilities of the post. However, the duties of the post may change and develop over time and may therefore be amended in consultation with the post holder,

1.Quality & Improvement

· Applies principles of Good Manufacturing Practice in all areas of projects operations

· Actively participate in internal process improvement program and initiatives

2.Communication & Liaison (Internal & External)

· Collaborate with internal project management, QA and Production team

· Work and liaise with the Production Team to provide support on the development of existing or new production, QC and Pharmacy processes

· Work and liaise with the Production Team to provide input into production scheduling process

· Work and liaise with the Production Team to provide support on logistics / distribution of products

· Work and liaise with external suppliers to identify all materials (including raw material, packaging material and consumables) required for the manufacture of project specific products

· Work and liaise with QA team to ensure project specific components, raw materials and bulk products are released and meeting project specific deadline

· Work and liaise with QA team to facilitate closure of Quality Exception Reports & Change Controls where appropriate

· Work and liaise with Qualified Person to ensure finished products are certified and released according to project specific deadline

· To draft and develop relevant operational GMP/GDP documentation including but not limited to the following:

• product specifications

• QC & stability specifications

• raw material specifications

• product specification file

• batch records (including label design)

• logistics documentation

· Coordinate and communicate of all relevant activities both internal and external to ensure that all services and products are delivered within specific timeline.

· To provide back up support to other members of the Project Team

· To facilitate and participate customer teleconferences, visits and audits as required.

3.Documentation & Reporting

· To maintain study filing systems and maintain accurate records for all work undertaken

· Timely provision of reports and other project information for internal and external stakeholders

· Monitor product activities and day to day business

· Collect and collate all relevant information relevant for project set up, including but not limited to the following:

• Details of study design

• Study protocol

• Label text (facilitate translation if applicable)

• Randomisation lists

• Pack size and presentation

• Quantity and number of campaigns required

• Distribution documentation requirements

4.PROFESSIONAL RESPONSIBILITIES

· To always behave in a manner that is professional, positive and polite to all staff and visitors.

· To adhere to the Company values at all times when representing the Company

· To be accountable for own professional actions

· To be responsible for his/her own professional development and participate in maintaining their training manual in accordance with the QMS and individual performance reviews

GENERAL RESPONSIBILITIES

Health and Safety at Work

The post holder is required to:

· Take reasonable care for the health and safety of himself/herself and other persons who may be affected by their actions or omissions at work.

· Co-operate with the employer in ensuring that all statutory and other requirements are complied with.

· To improve understanding of hazards specific to the facility, Production & operational services & COSHH materials and highlight ways of reducing risks to staff.

· To be one of the site’s First Aiders

Confidentiality & Data Protection

The post holder has a responsibility to comply with the Data Protection Act, GDPR and maintain confidentiality of staff, clients, and company business/knowhow. If you are required to process information, you should do so in a fair and lawful way, ensuring accuracy is maintained. You should hold information only for the specific registered purpose and not use or disclose it in any way incompatible with such a purpose. You should disclose information only to authorised persons or organisations as instructed. Breaches of confidentiality in relation to information will result in disciplinary action, which may include dismissal. Employees are expected to comply with all Company policies and procedures and to work in accordance with the Data Protection Act & GDPR. For those posts where there is management or supervision of other staff it is the responsibility of that employee to ensure that their staff receive appropriate training

Conflict of Interest

The Company is responsible for ensuring that staff do not abuse their official position, to gain or benefit themselves, their family or friends. The employee must disclose any potential conflict of interest to the RenaClinical Board as soon as it becomes aware/known to the employee

Equality and Diversity

The Company values equality and diversity in employment and in the services we provide. It is committed to promoting equality and diversity in employment and will keep under review our policies and procedures to ensure that the job related needs of all staff working in the Company are recognised. The Company aims to ensure that all job applicants, employees or clients are treated fairly and valued equally regardless of sex, marital status, domestic circumstances, age, race, colour, disablement, ethnic or national origin, social background or employment status, sexual orientation, religion, beliefs, HIV status, gender reassignment, political affiliation or trade union membership. Selection for training and development and promotion will be on the basis of the individual’s ability to meet the requirements for the job.

You are responsible for ensuring that the Company’s policies, procedures and obligations in respect of promoting equality and diversity are adhered to in relation to both staff and services.

Standards of dress

Employees are expected to dress in casual or smart casual attire unless the day’s tasks require otherwise. Employees must always present a clean, professional appearance. Everyone is expected to be well-groomed and wear clean clothing, free of holes, tears, or other signs of wear and comply with the facility gowning requirements stipulated by local procedures

Environmental Policies

The Company accepts its environmental responsibilities and recognises its obligation to reduce the impact of business activities on the environment in accordance with the Company Environmental Management Policy. All employees must comply with the policy and are encouraged to propose opportunities for reducing further the Company’s environmental impact

Job Types: Full-time, Permanent

Salary: £22,550.00-£28,350.00 per year

Additional pay:

• Bonus scheme

Benefits:

• Company pension
• On-site parking

Schedule:

• 8 hour shift
• Day shift

COVID-19 considerations:
Testing, social distancing and PPE requirements are required for all staff working on site

Work remotely:

• No