Qc Materials Specialist Secondment jobs at Ge Healthcare in Ireland, Cork

Roles and Responsibilities:

• Carry out routine analysis on Finished Product samples ensuring compliance with cGLP/cGMP and that turnaround times are met. The testing carried out includes but is not limited to: HPLC, Osmolality, Organic Iodine, Inorganic Iodine, Thin Layer Chromatography, Free aromatic amines, pH, RI, Trom’s, EDTA, Technical tests, Extractable volume.
• Assisting in the maintenance of the stability program
• Actively involved in Investigations
• Logging of samples in LIMS
• Entering results on LIMS, checking results are within specification and also task approval.
• Always ensure compliance with EHS, actively participate in EHS activities and 5s.
• Perform routine instrument calibration checks at appropriate times.
• Preparation and control of Standard Operating Procedures and always ensuring compliance with cGMP guidelines.
• Completion of Documentation for Batch Release process.
• Assisting in the provision of trends
• Assist in audits.
• Generation/ reporting of Key performance indicators for the group.
• Ensure compliance with current pharmacopoeias and all regulatory/company guidelines.
• Interaction with other departments e.g., QA, BU, Sterility assurance etc.
• Keep colleagues informed of current issues and developments as appropriate.
• Carry out additional duties as deemed necessary by your PTL/Senior Analyst PRINCIPAL QUALIFICATIONS:
• A third level Science Qualification
• SkillsREQUIRED: Good communications skills, excellent time management skills, flexibility and agility will be required. Openness to change. Proven ability to work on own initiative and deliver expectations. DESIRED WORK EXPERIENCE: Pharmaceutical experience in a GMP regulated laboratory environment.

Roles and Responsibilities:

• Carry out routine analysis in QC Raw Material Team samples ensuring compliance with cGLP/cGMP and that turnaround times are met. The testing carried out is on In coming materials.
• Actively involved in Investigations
• Always ensure compliance with EHS, actively participate in EHS activities and 5s.
• Perform routine instrument calibration checks at appropriate times.
• Preparation and control of Standard Operating Procedures and always ensuring compliance with cGMP guidelines.
• Completion of Documentation for Batch Release process.
• Assisting in the provision of trends
• Assist in audits.
• Generation/ reporting of Key performance indicators for the group.
• Ensure compliance with current pharmacopoeias and all regulatory/company guidelines.
• Interaction with other departments e.g., QA, BU, Sterility assurance etc.
• Keep colleagues informed of current issues and developments as appropriate.
• Reasonable level of overtime will be required to facilitate the business needs.
• Carry out additional duties as deemed necessary by your PTL/Senior Analyst

PRINCIPAL QUALIFICATIONS:

A third level Science Qualification

Good communications skills, excellent time management skills, flexibility and agility will be required. Openness to change. Proven ability to work on own initiative and deliver expectations.

DESIRED WORK EXPERIENCE:

Pharmaceutical experience in a GMP regulated laboratory environment.

• Provide quality assurance oversight on all X Ray & MRI products manufactured by GEHC, Cork covering all stages of product lifecycle i.e. preparation, manufacture, testing, packaging, labelling, storage, transportation, distribution, complaint handling, documentation and record keeping.

• Work with other internal support functions to ensure all processes are designed, implemented and maintained to meet relevant requirements.

• Manage the batch record review and final QP disposition of manufactured batches as per Annex 16 release requirements.

• Review complaints as required related to GEHC Cork and take appropriate action to prevent recurrence.

• Involvement in regular audits to assess the effectiveness of quality systems, identify any non-conformances and recommend corrective actions.

• Maintain accurate records of all quality assurance activities.

• Coordinate the conduct of investigations into quality issues identified through internal or external sources.

• Collaborate with distributors and customers on quality matters.

• Actively participate in cross functional investigations/projects as required.

• Ensure timely communication and reporting to senior management regarding significant product quality issues.

• Bachelor’s degree (2.1 or above) in a relevant discipline such as: Pharmacy, Medicine, Veterinary Medicine, Chemistry, Pharmaceutical Chemistry and Technology, Biology or equivalent

• Strong experience in a Quality Assurance role within a Life Sciences industry.

• Strong knowledge of cGMP requirements, EU Directives & Regulations 2001/83/EC, Eurdralex Volume 4, specifically focusing on Annex 13 & Annex 16 requirements .

• Advanced computer skills, particularly Microsoft Office Suite, Excel. Familiarity with validated quality systems e.g. Trackwise Digital, Veeva Vault and Compliance Wire a bonus.

• Proficiency in written and spoken English language essential.

Inclusion and Diversity

Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support.

• Implement the EHS Framework 3.0, working in partnership with the leadership team and element owners to support compliance, manage complex issues, lead long-term EHS planning, and support the overall site strategy.

• Implement programs, tools, and training to assist the site in ensuring compliance with legal requirements, implementing GE EHS programs, meeting business expectations and ensuring continuous improvement.

• Analyze and communicate performance against expectations, provide feedback, establish and track required actions to improve the EHS environmental programs.

• Sustain a world class EHS program and safety culture; ensure robust pipeline and process for driving excellence in the workplace (Pollution Prevention, Waste Management, Chemical Management, etc).

• Build, retain and analyze data for process efficiency (Waste, Water, Air).

• Provide technical support and guidance to site projects.

• Manage legal requirements as required.

• Ensure that you are fully aware of, and comply with the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position

• Complete all planned Quality & Compliance training within the defined deadlines

• Identify and report any quality or compliance concerns and take immediate corrective action as required

• Work with Quality to support QMS initiatives.

• Bachelor’s Degree or Higher Qualification in Occupational Safety, Health, Environment, Engineering, Chemistry degree or equivalent.

• Basic experience with proven EHS knowledge and background in a pharmaceutical, or manufacturing environment.

• Strong interpersonal and communications skills.

• Ability to work in a matrix environment, influence and motivate colleagues to achieve a unified goal.

• Working knowledge of EHS management system would be advantageous

• Skill sets and experience in Industry related Environmental subjects, such as Air and Water Pollution Prevention, Hazardous and Non-Hazardous Waste Management, Chemical Management legislation, etc are desirable.

• Ability to simultaneously manage multiple projects and other responsibilities, adjust to changing priorities.

• Knowledge of European, National & Local regulations, codes & standards, reinforced by a solid understanding of healthcare industry and EHS standards.

Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support

• Act as a technical and compliance liaison between QC functional teams and Operations/Engineering/QA.

• Provide technical support on QC instrumentation and product testing issue within the QC unit.

• Respond actively and troubleshoot test/instrument performance issues as notified by Operations/Engineering/QA.

• Technical expert in a wide range of chemical and microbiological equipment.

• Familiar with 21 CFR part 11 and how it applies to laboratory instrumentation.

• Sourcing, purchase and qualification of laboratory equipment.

• Carry method validation activities, through writing and executing protocol.

• Research new technologies to improve laboratory compliance and efficiency.

• Ownership of quality systems actions (IR's,CAPA,CC) ensuring timely closure and performance trending.

• Degree in Chemistry/ Microbiology, or in a science subject.

• Basic pharmaceutical experience in a GMP regulated laboratory environment

• Experience/ knowledge dealing with HPLC/ICP instrumentation is desired

• Highly attentive to detail

• Self motivated, goal driven

• Experience in technical problem solving

• Good organisational skills

Total Rewards

Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support.

• Act as a technical and compliance liaison betwenn QC functional teams and Operations/Engineering/QA.

• Provide technical support on QC instrumentation and product testing issue within the QC unit.

• Respond actively and troubleshoot test/instrument performance issues as notified by Operations/Engineering/QA.

• Ownership of equipment system administration, calibration and maintenance to ensure availability for use.

• Technical expert in a wide range of chemical and microbiological equipment.

• Familiar with 21 CFR part 11 and how it applies to laboratory instrumentation.

• Sourcing, purchase and qualification of laboratory equipment.

• Support method validation activities, through writing and executing protocol.

• Support maintenance of laboratory servers and integration of new equipment as relevant.

• Research new technologies to improve laboratory compliance and efficiency.

• Ownership of quality systems actions (IR's,CAPA,CC) ensuring timely closure and performance trending.

• Degree in Chemistry/ Microbiology, or in a science subject or equivalent.

• Basic pharmaceutical experience in a GMP regulated laboratory environment

• Experience/ knowledge dealing with HPLC/ICP instrumentation is desired
  

• Highly attentive to detail

• Self motivated, goal driven

• Experience in technical problem solving

• Good organisational skills

Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support.

• Managing and developing the QC analyst team to provide safe, compliant, timely and cost effective QC support to the plant

• Ensuring product testing is scheduled and completed in a timely manner in compliance with cGxP.

• Provide technical support to the Analyst team for the investigation and closure of investigations

• Responsible for leading and delivering QC projects

• Defining Quality Control Policies, in consultation with QA guidelines

• To take the responsibility for delivering the departments functional goals including people development.

• Ensuring systems are in place to assure QC activities are carried out in compliance with product licence commitments, cGMP and Quality standards

• Fostering an environment of continuous improvement and providing leadership in this area by identifying and implementing LEAN practices to deliver efficiency, cost reduction, quality and service level improvements.

• Leading local and cross functional investigations

• Responsible for managing a programme to develop people and technical skills to implement new technologies and apply best practice in QC techniques and systems.

• Primary degree in Science essential supported by a sound technical background in a chemistry discipline or equivalent

• Strong supervisory experience in Pharmaceutical industry desirable

• Excellent leadership and communication skills are a pre-requisite for this role.

• Highly attentive to detail

• Good organizational and communication skills

• Willingness to learn

• Ability to work as part of a team but also self-motivated

• Ability to work under pressure

• Strong problem-solving skills and a proactive attitude towards identifying and addressing quality issues.

• Ability to work independently and collaboratively in a fast-paced, dynamic environment, managing multiple priorities and deadlines effectively.

• Strong analytical skills and attention to detail, with the ability to identify, troubleshoot, and resolve issues.

• Excellent communication skills, with the ability to convey technical information effectively to both technical and non-technical stakeholders.

Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support.