Manufacturing Compliance Specialist
This job does not exist anymore.
Try running a new searchor browse our vacancies.
Or fill in the form below to receive job alerts.
| Job Type | Contractor |
| Location | Sligo |
| Area | Sligo, Ireland |
| Sector | Operations & ManufacturingRegulatory |
| Start Date | |
| Advertiser | Darcy Ainscough-Denton |
| Telephone | +353 1 574 6266 |
| Job Ref | 1002658 |
| Job Views | 443 |
- Description
- Team Horizon is seeking a Manufacturing Compliance Specialist to join our client in Sligo. This role reports to the Quality Systems Manager and will assist the site in implementing a new product and ensure compliance throughout.
Why you should apply:
This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.
There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve people’s lives.
Our client is developing the capability to produce all its medicines, helping to ensure continuity of supply of our medicines as they expand internationally.
What you will be doing:
Ensure that all products leaving the client’s Biologics site meet the standards required for marketed and investigational drug products.
Ensure that products and aseptic process simulations manufactured at the client’s site meet the requirements of the end users, regulatory authorities and of the company.
Providing quality and compliance oversight and assistance to the Operations function of the company to manufacture products in compliance with all site policies and procedures.
Provide quality oversight during the aseptic processing of products.
Leading / Assisting in investigations arising out of product or manufacturing processes non-compliance.
Review/Audit of completed Batch Records.
Review of Manufacturing Logs as required.
Completion of Line Clearance activities.
Completion of Incoming Raw Material checks, including product status maintenance.
Provide Stability Program Support, e.g. sample pulls, weekly checks, protocol generation as required.
Finished product status maintenance, including labelling as required.
Administration of Quality Logs, e.g. QA Hold, Sample Request, VCR.
Lead operations floor daily walk around of manufacturing areas.
Drive continuous improvements and simplify site processes and procedure, specifically relating to the Operations function to ensure compliance is maintained at all times.
Other support as deemed necessary.
Other duties as assigned.
Ownership/Accountability
Every employee has a personal responsibility to commit to the client’s Vision, to engage and align with the client’s Strategic Imperatives, and to consistently execute in accordance with the client’s Operational Pillars and the cient’s Ways of Work.
The position has a high level of autonomy and individuals are expected to work on their own initiative.
Shows a high level of tenacity to ensure closure of issues and projects.
Demonstrates an ethos of Right First Time at all times.
This position impacts on product quality and technical performance as well as manufacturing operations.
Expected to handle all day-to-day operational quality issues. If problems occur, can consult their leader.
Adheres to and follows all procedures policies and guidelines ensuring compliance with cGMP and HPRA/FDA regulations and company policies, procedures and guidelines.
Influence/Leadership
Expected to influence operations area owners to ensure that quality issues are identified, and appropriate corrective actions are implemented to maintain compliance.
Provides guidance to the operations functions as required to maintain a compliant efficient relationship.
Is a site SME on compliance and provides guidance on same.
May be required to support Cross functional teams and cost improvement projects.
Decision Making/Impact
Decision making within confines of quality systems in relation to applicable regulatory and international standards.
Expected to handle all day to day quality issues/queries from the operations function, however, if a major problem occurs they will confer with relevant personnel or Team Leader.
Decision making within confines of agreed responsibility with Team Leader.
Supervision Received
Individual is given authority to carry out their duties without close supervision.
Reports to Quality Operations Manager.
Goals are reviewed on a regular basis and formal performance reviews are carried out once per year.
Supervision Provided
No direct supervisory responsibilities.
Close contact with operations personnel at all levels.
Comply with the EHS policy and procedures and demonstrate EHS best practices in all work activities;
Continually be conscious of your own safety and that of others, always complying with safety notices and barriers;
Report any EHS incidents and/or Near Misses (unsafe acts and conditions) immediately to your supervisor and always raise the event in EHS system.
Support a culture of EHS excellence by recognizing and submitting opportunities for EHS improvement on EHS system.
Attend all required EHS training and medical surveillance programs;
Wear PPE as required.
Decision Making/Impact
Decision making within confines of quality systems in relation to applicable regulatory and international standards.
Expected to handle all day-to-day quality issues/queries from the operations function, however, if a major problem occurs they will confer with relevant personnel or Team Leader.
Decision making within confines of agreed responsibility with Team Leader.
Supervision Received
Individual is given authority to carry out their duties without close supervision.
Reports to Quality Operations Manager.
Goals are reviewed on a regular basis and formal performance reviews are carried out once per year.
Supervision Provided
No direct supervisory responsibilities.
Close contact with operations personnel at all levels.
What you need to apply:
Educational Requirements
Third level degree in science, quality or engineering discipline is essential.
Ideally previous experience in a quality role.
Technical/Business Knowledge Required
A minimum of three years’ experience in a quality/operations role in a highly regulated GMP environment. Experience in pharma / biologics desirable.
A strong knowledge of regulatory requirements is required.
Cognitive Skills
Requires a high level of attention to detail and mental concentration, to ensure accuracy and total compliance with procedures at all times.
Requires proven problem-solving skills and the ability to adapt to new requirements.
Requires innovative thinking, where new and untested solutions are proposed, demonstrated and implemented on a regular basis.
Must be results driven striving to meet all targets and metric standards as set by site/department and division leaders.
Requires total commitment to quality and maintaining a high standard of work at all times.
Demonstrates the highest levels of integrity and a strong work ethic at all times.
Strong communication skills both verbal and written are required for the execution of this role.
Strong interpersonal skills are required
Supports the principles of Perfect Performance.
