QC Planner

Orion Group Life Sciences are currently recruiting a QC Planner on behalf of our Multinational Biopharmaceutical Client based in Sligo on an initial 6-Month contract with potential to extend.
 
 
Purpose: The Quality Control Laboratory Planner for the Quality Control Laboratory is responsible for the planning and control of the testing schedule for all Sligo MHR manufactured product, incoming goods and utility monitoring. The QC Planner is responsible for preparing short-term and long-term testing schedules and incorporating non-routine testing needs such as process validation testing, customer complaint testing, testing arising from non-conformances, etc. into the QC testing schedules. The QC Planner serves as the key contact within the QC department for all Sligo MHR QC department customers on the status of testing and QC release, and for inclusion of new testing requests in the short-term and long-term testing schedules. The role requires the building of excellent relationships, within and outside of the QC department, to ensure the optimum testing schedule is agreed with all stakeholders.
 
Responsibilities:

• Complete and adhere to all training requirements for job role, including company-required and role-specific training.
• Coordinate with key stakeholders including API, Drug Product, Synthroid , QA to ensure timely testing for product.
• Coordinate with key stakeholders including QC Management and QC testing team, to ensure timely release of testing results to support the manutfacturing and supply chain departments.
• Attend and represent QC at key Site meetings including but not limited daily QC Tier 1 meetings, QC Tier 2 meetings, weekly Site Scheduling meetings, Tier 2 meeting with API and Drug product/Synthroid, MPS, 24 month plan API and DP etc.
• Host and chair the weekly QC scheduling meeting, and develop short-term and long-term testing schedules in collaboration with the QC team, and with site stake holders.
• Following the weekly QC Scheduling meeting, issue the weekly QC testing schedule to stakeholders. Maintain the API, Drug product and Synthroid tracker.
• Work closely with QC Supervisors to develop and maintain Training Matrices for each testing team, to ensure proper coverage in the testing teams of the QC laboratory by trained, skilled QC Analysts, and to ensure adequate cross training, for testing capability within each testing team.
• Work closely with QC team to ensure adequate instrumentation availability, and optimized instrumentation utilisation in support of the testing schedules.  
• Work closely with QC Supervisors to optimize resource capacity and testing efficiency in suport of the testing schedules.
• Work closely with Opex to analyse data for improvements.
• Works with key stakeholders, internal and external, to QC, to identify and prioritise testing committments and provides updates on testing status and schedule changes, as needed.
• Recommend solutions to improve workflow, testing capabilities, and testing efficiences.
• Monitor and report laboratory performance metrics related to scheduling, schedule adherence, and performance against QC lead times. 
• Schedule project related activities external and internal to QC related to changes in manufacturing and QC laboratory.
• Perform other duties within the QC function as directed by the QC Manager.

 
Qualifications:
Bachelor’s degree or above in Chemistry, a related Science, or a related planning and scheduling discipline.
3-5 years of related pharmaceutical experience
Job/Technical Skills

• Experience of planning or scheduling in a QC laboratory environment would be a distinct advantage.
• Experience and understanding of testing in Quality Control laboratories.
• Good understanding of pharmaceutical manufacturing operations.
• Computer literate; proficiency in using Microsoft Office Suite.
• Understanding of Lean Manufacturing concepts, and familiarity with the QC Laboratory Lean Laboratory model.
• Must have demonstrated time management skills, organizational skills, project management skills, and administrative skills.
• Effective communication skills with the ability to work cross functionally across different departments, and across different levels within the company, with a proven ability to build and develop strong relationships cross functionally.
• Ability to influence positively and skillfully to find common ground with a wide range of stakeholders to achieve the optimum testing schedule.

Cognitive/Business Skills

• A self-starting, self-motivated, leader with highly developed interpersonal skills
• Excellent written and oral communication skills, experience in presenting complex data to all levels of leadership.
• Excellent organizational skills, problem solving and conflict resolution, and the ability to develop win/win relationships with other teams and organizations.
• Experience of working in a busy laboratory environment is an advantage.
• Strong Organizational and Planning skills
• Capability to prioritize and multi-task.
• Excellent interpersonal and communication skills.
• High accuracy and strong attention to detail
• Excellent teamwork skills
• Initiative and Innovation to generate and implement improvements

 
Ownership/Accountability

• This role is accountable for supporting a positive developmental culture with the organization while ensuring compliance with Quality policies.
• Requires good knowledge of Company Policies and Procedures and involves working towards general results to achieve organizational needs.
• The position has a high level of autonomy and individuals are expected to work on their own initiative.
• Always demonstrate an ethos of Right First Time.
• Adheres to and follows all procedures, policies and guidelines ensuring compliance with cGMP regulations and company policies, procedures and guidelines.
• Shows a high level of tenacity to ensure closure of issues.

Influence/Leadership

• Practical knowledge and experience of implementing Lean and/or Six Sigma.
• Advanced understanding and demonstrated application of change management across multiple functional areas.
• Proven track record managing projects.
• Ability to operate in a matrixed environment with the ability to influence & persuade key stakeholders and to constructively deal with conflicts.

Supervision Received

• The position reports directly to the Senior QC Manager who will ensure goals are defined.

Supervision Provided

• No direct reports.

 
 


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