R&D Compliance Lead

3 weeks ago


Galway, Galway, Ireland Pharmaceuticalcarrier Full time

With a strong presence in 96 countries, we are committed to providing innovative and effective solutions to meet the needs of our customers.
Our Research & Development team is seeking a dynamic and passionate individual to join us as an R&D Compliance Lead.
Job Summary: As the R&D Compliance Lead, you will be responsible for ensuring that all laboratory procedures and practices are compliant with pharmacopoeia's, regulations, and industry standards.
You will oversee the calibration and maintenance of laboratory equipment, ensure data integrity is maintained, and participate in internal and external audits of the R&D function.
Additionally, you will maintain and follow all relevant Standard Operating Procedures (SOPs) and keep records up to date.
Key Responsibilities:
Generate, review, and approve existing methods with reference to pharmacopoeia's, specifications, regulations, and industry standards
Display technical competency and a full understanding of methods and equipment related to HPLC, IR, UV, dissolution, and physical testing
Calibrate and maintain laboratory equipment and liaise with service engineers as required
Check analytical results and approve raw materials, finished products, and packaging materials
Ensure data integrity is maintained in the R&D laboratories and procedures are followed
Maintain and follow all relevant Standard Operating Procedures (SOPs)
Review and approve all pilot batch documentation including Work Orders and Process Validation Protocols
Review and approve stability protocols for R&D pilot batches in line with ICH/VICH Guidelines
Ensure timely feedback of all queries as appropriate
Bring to the notice of the team leader/supervisor any discrepancies, deviations, or non-conformances in testing or work practice
Complete OOS investigations and follow up on corrective actions
Amend lab procedures (SOPs, FPPs, ECPs, etc.) as and when appropriate
Participate in internal/external audits of the R&D function
Ensure that existing R&D and Quality procedures are followed in all areas and where appropriate suggestions/change control forms prepared so that the quality system can be improved
Encourage and maintain good housekeeping and hygiene within the laboratory
Proactively create and encourage a safe working environment, adhering to laboratory safety measures at all times
Lead by example, ensuring that your work area is kept tidy and that GLP/GMP standards are adhered to at all times
Ensure records pertaining to R&D are kept up to date and filed properly
Provide support as required to the R&D Manager/Head of R&D
Any other duties as assigned by the R&D Manager/Head of R&D
Competencies:
Establish strong working relationships with others, building team rapport, and creating a cohesive team environment
Display a positive outlook with strong coaching skills, maintaining interest at all times
Take a methodical, systematic, and structured approach to organizing work
Make effective and consistent decisions in a timely manner
Take personal responsibility for making a decision and taking action within their own area
Escalate issues appropriately
Take action to correct poor performance by being fair and consistent in approach
Display flexibility, willingness to succeed and goes the extra mile
Qualifications:
3rd level qualification
Degree in Science Discipline or equivalent
Biology and/or chemistry courses/background required
Practical knowledge of analytical techniques
Strong verbal and written communication skills
Strong computer skills in MS Office
If you are interested in this exciting opportunity to be part of a dynamic team, please submit your resume and cover letter to us.
We are an equal opportunity employer and welcome applications from all qualified individuals.
For more articles,
Kindly Click
here
.
For pharmaceutical jobs, follow us on
LinkedIn
For more jobs, kindly visit our job section.
#J-18808-Ljbffr


  • R&D Compliance Lead

    3 weeks ago


    Galway, Galway, Ireland Pharmaceuticalcarrier Full time

    OverviewWith a strong presence in 96 countries, we are committed to providing innovative and effective solutions to meet the needs of our customers. Our Research & Development team is seeking a dynamic and passionate individual to join us as an R&D Compliance Lead.Job Summary: As the R&D Compliance Lead, you will be responsible for ensuring that all...


  • Galway, Galway, Ireland beBeeProjectManagement Full time €60,000 - €80,000

    We are seeking a seasoned Project Director to spearhead complex R&D initiatives at the forefront of technological advancements. As a strategic leader, you will drive innovation while balancing precision and delivery in high-pressure environments.Responsibilities:Guide R&D activities from conception to completion, ensuring seamless project execution.Serve as...


  • Galway, Galway, Ireland beBeeLeadership Full time €100,000 - €120,000

    Job Title: Senior R&D Manager">">We are seeking an accomplished and forward-thinking Senior R&D Manager to lead our R&D Lifecycle Management team. This is a fantastic opportunity for a visionary leader who can shape the LCM function of our R&D department.">Lead a growing R&D LCM team, providing strategic direction and guidance on technology and program...

  • R&D Innovations Lead

    2 weeks ago


    Galway, Galway, Ireland beBeeResearch Full time €90,000 - €120,000

    Key Leadership Position for R&D InnovationThe ideal candidate will lead our team of engineers in driving cutting-edge medical device development. With a strong background in Medical Device Engineering, the successful applicant will oversee strategic planning, team management, and project delivery.This role is critical to our organization's success, requiring...


  • Galway, Galway, Ireland Scientificjobs Full time

    Social network you want to login/join with:Job title:Principal R&D EngineerLocation:Parkmore Business Park, Galway (Hybrid working)Benefits:Excellent salary, 15% bonus, Hybrid working, Full family healthcare and pension contributionCompany:My client are a rapidly growing medical device company offering a highly differentiated solution in SFA...


  • Galway, Galway, Ireland beBeeLeadership Full time €80,000 - €100,000

    Job Title: R&D Catheter Development LeadAbout the Role:The R&D Catheter Development Lead will be part of a dynamic team in Galway, dedicated to developing innovative catheter solutions for neurovascular diseases.Provide technical leadership and ownership of critical tasks in new product development catheter projects.Liaise with key opinion leaders to...


  • Galway, Galway, Ireland Independent Search Solutions Full time

    A great opportunity for a R&D Engineer who has experience of Leading Teams and is looking to move into a formal Project Management position.My client who develops a range of consumable Medical Device products used across healthcare; has an expanding R&D Team with a strong culture of personal development and internal career promotion.You will need to have...

  • Senior R&D Team Lead

    2 weeks ago


    Galway, Galway, Ireland beBeeLeadership Full time €80,000 - €100,000

    Project LeaderThe company is looking for a highly skilled Project Manager to lead its R&D team in Galway. The successful candidate will be responsible for the execution of new product development catheter projects.This role offers an exciting opportunity to work with a cutting-edge biomedical operation and be part of a global market leader. As a key member...


  • Galway, Galway, Ireland beBeeEngineering Full time €40,000 - €60,000

    Structural Heart R&D EngineerJob OverviewWe are seeking a skilled Structural Heart R&D Engineer to support the development of next-generation transcatheter heart valve devices in a fast-paced, innovative medical device environment.Key ResponsibilitiesPerform testing, calibration, and maintenance of medical device components and equipment.Support and lead...


  • Galway, Galway, Ireland beBeeResearch Full time €150,000 - €200,000

    Job OverviewLead a dynamic R&D team to deliver impactful medical device solutions.This fast-growing organization has an extensive research, development, and clinical program in place. As the Director of Research and Development, you will be responsible for directing the team to achieve milestones on time.The ideal candidate will possess strong leadership...