QA Coordinator

QA Coordinator

Reporting to: Covalen Site Lead

Department: Quality

Main Purpose and Objectives of Position:

Covalen is the chosen vendor onsite for the purpose of managing contracting staff fulfilling predominantly administration centric roles. The Co-ordinator plays a crucial role in managing administrative tasks to ensure smooth operations. Their primary responsibilities include executing and coordinating activities across various departments, managing key business deliverables, and acting as a subject matter expert for process consistency. They also drive improvements in documentation management processes and develop business processes and practices. Additionally, coordinators are responsible for training new personnel, cross-training to avoid service gaps, and assisting with KPI/metrics generation. Overall, they ensure efficient administrative support, contributing to the sector's productivity and compliance.

Key Responsibilities:

QA Assistant Duties:

·       Provide key support to the QA function within Stability Management, Material Management/Supply Chain and QA support. 

·       Co-ordination of the Stability Program- Management including study activations, creation and approval of stability studies. Receipt and activation of stability samples. Equipment monitoring and stability unit trend reviews

·       Responsible for the Packaging /preparation of the Product in the Laboratory.

·       Responsible for quality-related matters specific to area of responsibility, including any Deviations and associated Investigations

·       Generation of Certificates of Analysis/ Conformance to support shipping requirements.

·       QA review of Batch Records, Cleaning Tickets and Logbooks

·       Assist with reconciliation of laboratory notebooks as required.

·       Carry out day to day activities in compliance with site safety policy and procedure. Promote and encourage safe practices and promptly report any safety concerns.

·       Provide back up for specific QA Assistant activities as required

·       Work effectively within the QA function to deliver on objectives

·       Site stability program co-ordination.

·       Co-ordinate with labs to ensure stability sample pulls are performed within outlined pull window and align this with the lab.

·       Participating member of a New Product Introduction team of the product’s stability requirements, e.g., stability cabinet/storage capacity, stability simulator, stability specification and time-point requirements.

·       Study management for Stability program lots, study timepoint pulls, completion of Stability Studies. Flag the batch, Register the Parent lot and complete Study Activation, Receiving Stability Parent Samples.

·       Development of Study Lot Details and creation of Graphics on Darwin Stability Program.

·       Study completion and notification to management for final approval

·       monitoring stability units –alarm response, review of temperature/ humidity trends to ensure alarm response/ deviation are complete.

·       Materials Management/Supply Chain

·       Creation of Certificates of Analysis and Certificates of Compliance for weekly Shipping using various systems and reports, working with Shipping schedule.

·       Supporting QA team to ensure Non-Routine Certificate of Analysis are maintained

·       Perform COA compliance checks for Consumables and raw materials.

QA Assistant Coordinator Duties:

·       Compile data for batch disposition i.e. genealogy reports, batch record reconciliation & deviation/change control reports.

·       Batch record & logbook reviews for biotech

·       Veeva Doc Controller – issuing, routing retiring etc. 

·       Review and approval of raw material Certificates of Analysis

·       General Q Admin support

·       Manage the key business deliverables for QA assistant group 

·       Act as a process SME ensuring consistency of execution across all areas. 

·       Escalate critical quality issues as appropriate to Quality Management Organise personnel coverage with Covalen site Manager 

·       Developing and implementing business processes and practices improvements 

·       Manage and perform raining of personnel new to the team to ensure qualification for the role 

·       Cross training personnel to ensure no service gaps 

·       Assist with KPI/metrics generation  

·       Co-ordinate all tasks for QA-Assistant

Requirements:

·       Level 8 degree in a relevant discipline (Hons BSc, MSc, Chemistry, Engineering, Quality, or other related discipline)

·       3 years’ experience in the Pharmaceutical and Biopharmaceutical sector

·       A minimum of 2 years Quality experience in a Pharmaceutica environment

·       Ability to work on own initiative and to challenging schedules

·       Excellent interpersonal and communication skills.

·       Experience managing third party relationships desirable. 

·       Experience in document management.

·       Experience with document management in the pharmaceutical sector

·       Excellent communication skills in English

·       System experience is an advantage: SAP, Veeva Vault, Trackwise, Darwin, SuccessFactors, MS Word, Excel, Teams.

Key Attributes:

·       Coordination – Positive Influence: Demonstrated ability to address issues as they arise and act in a positive collaborative manner. Faces up to issues quickly and directly acts when necessary or asks for help. Trusted within their team, with a demonstrated commitment to follow through on actions. Is interested in own performance and seeks feedback to improve.

·       Ability to Lead – Is seen as a team player and works collaboratively within team and across the business. Can motivate others and is someone people enjoy working with. Can proactively bring a group with them to get a task completed where needed.

·       Communication – Demonstrated effective communication skills both written and oral. Willing to speak up on topics in group situations or 1:1 in a positive and constructive way. Demonstrated credibility and positive influence through communication style within their team.

·       Relationship Builder – Approachable: is easy to approach and talk to, spends the extra effort to put others at ease, actively listens and builds rapport with team members. Is interested in, and cares about others in the team and understands people and their perspective and can use this insight to remain calm and work through situations objectively.

·       Business Knowledge – Relevant experience in the business and demonstrated performance in delivery. Shows interest in how the business works and looks for opportunities to learn. Looks at better, simpler ways and will take initiative and will run proactively with actions, improvements, and non-routine activities. Demonstrated self-management, prioritisation, and organisational skills.

·       Decision Making – Demonstrated ability to raise issues with the team and Covalen management if there is a potential for a problem in the process. Assist others in the decision making process

·       Learning agility and Curiosity – Learns quickly and is proactive in obtaining new knowledge and skills. Open to different experiences/perspectives including learning new technologies and consistently getting involved in troubleshooting.

·       Flexibility – Demonstrated ability to be flexible in working arrangements depending on business needs.