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QA Manufacturing Compliance Specialist (Biologics)

ID
14514
Location
Sligo, Ireland
Role Type
Contract
Contact
Hannah Doyle
Email
engineering@hero.ie
Phone
+353 86 107 0950
LinkedIn
click here

QA Manufacturing Compliance Specialist (Biologics)

Similar Jobs

QA Manufacturing Compliance Specialist (Biologics)

Job Dept: Quality Assurance
Reports to: Quality Operations Manager

Responsibilities:

  • Ensure that all products leaving the Biologics Ballytivnan site meet the standards required for marketed and investigational drug products.
  • Ensure that products and aseptic process simulations manufactured at the Biologics Ballytivnan site meet the requirements of the end users, regulatory authorities, and the company.
  • Provide 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, including aseptic intervention observation.
  • Lead or assist in investigations arising out of product or manufacturing processes non-compliance.
  • Review and audit completed Batch Records.
  • Review Manufacturing Logs as required.
  • Complete quality review of operations documentation (SOPs, JSTMs, Risk Assessments).
  • Complete Line Clearance activities.
  • Complete Incoming Raw Material checks, including product status maintenance (as required).
  • Provide Stability Program Support, e.g., sample pulls, weekly checks, protocol generation (as required).
  • Maintain finished product status, including labeling as required.
  • Administer Quality Logs, e.g., QA Hold, Sample Request.
  • Lead daily walk-arounds of manufacturing areas.
  • Drive continuous improvements and simplify site processes and procedures, specifically relating to the Operations function to ensure compliance is maintained at all times.
  • Provide other support as deemed necessary.

Requirements:

  • Third level degree in a science, quality, or engineering discipline.
  • Ideally, previous experience in a quality role.
  • A minimum of three years’ experience in a quality/operations role in a highly regulated GMP environment. Experience in biologics manufacturing is highly desirable.
  • Experience in aseptic processing gained within either a quality or operations role is highly 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.

Ownership/Accountability:

  • Has a personal responsibility to commit to the company’s Vision, to engage and align with the company's Strategic Imperatives, and to consistently execute in accordance with the company's Operational Pillars and 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 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:

  • May be required to support cross-functional teams and cost improvement projects.
  • 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 the same.

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.

Supervision Provided:

  • No direct supervisory responsibilities.
  • Close contact with personnel at all levels.

EHS Responsibilities:

  • 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 the EHS system.
  • Support a culture of EHS excellence by recognizing and submitting opportunities for EHS improvement on the EHS system.
  • Attend all required EHS training and medical surveillance programs.
  • Wear PPE as required.
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