Job Description Summary
We are seeking a dedicated QC Finished Product Analyst to join our team on a 12month fixedterm contract working on a 4cycle shift this role you will play a key part in ensuring that all finished product testing is carried out to the highest cGMP and cGLP standards supporting product release compliance and continuous improvement across the QC function. This position offers the opportunity to work with a wide range of analytical techniques while collaborating closely with crossfunctional teams in a fastpaced highly regulated environment.
Job Description
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 Troms EDTA Technical tests Extractable volume. complaints etc..
Assisting in the maintenance of the stability program
Actively involved in Investigations e.g. LIRs. etc..
Logging of samples in LIMS
Entering results on LIMS checking results are within specification and also task approval.
Ensure compliance with EHS at all times actively participate in EHS activities.
Perform routine instrument calibration checks at appropriate times.
Preparation and control of Standard Operating Procedures and ensuring compliance with cGMP guidelines at all times.
Completion of Documentation for Batch Release process.
Assisting in the provision of trends CPV etc..
Assist in audits.
Generation/ reporting of Key performance indicators for the group.
Be proactive in approach planning for future and implement improvements in an effective manner.
Develop areas of expertise in analytical testing in order to solve technical issues.
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.
Assist in the training and up skilling of colleagues.
Reasonable level of overtime will be required to facilitate the business needs.
Liaising with internal and external customers e.g. planning/ QA/ BU etc.
Carry out additional duties as deemed necessary by your Group Leader/ Supervisor.
Qualifications and Requirements
Desired Characteristics
Inclusion and Diversity
GE HealthCare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race color religion national or ethnic origin sex sexual orientation gender identity or expression age disability protected veteran status or other characteristics protected by law.
Behaviors
We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus and drive ownership always with unyielding integrity.
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 youd expect from an organization with global strength and scale and youll be surrounded by career opportunities in a culture that fosters care collaboration and support.
#LI-BG1
#LI-onsite
Additional Information
Relocation Assistance Provided: No
Required Experience:
IC
Job Description SummaryWe are seeking a dedicated QC Finished Product Analyst to join our team on a 12month fixedterm contract working on a 4cycle shift this role you will play a key part in ensuring that all finished product testing is carried out to the highest cGMP and cGLP standards supporting ...
Job Description Summary
We are seeking a dedicated QC Finished Product Analyst to join our team on a 12month fixedterm contract working on a 4cycle shift this role you will play a key part in ensuring that all finished product testing is carried out to the highest cGMP and cGLP standards supporting product release compliance and continuous improvement across the QC function. This position offers the opportunity to work with a wide range of analytical techniques while collaborating closely with crossfunctional teams in a fastpaced highly regulated environment.
Job Description
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 Troms EDTA Technical tests Extractable volume. complaints etc..
Assisting in the maintenance of the stability program
Actively involved in Investigations e.g. LIRs. etc..
Logging of samples in LIMS
Entering results on LIMS checking results are within specification and also task approval.
Ensure compliance with EHS at all times actively participate in EHS activities.
Perform routine instrument calibration checks at appropriate times.
Preparation and control of Standard Operating Procedures and ensuring compliance with cGMP guidelines at all times.
Completion of Documentation for Batch Release process.
Assisting in the provision of trends CPV etc..
Assist in audits.
Generation/ reporting of Key performance indicators for the group.
Be proactive in approach planning for future and implement improvements in an effective manner.
Develop areas of expertise in analytical testing in order to solve technical issues.
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.
Assist in the training and up skilling of colleagues.
Reasonable level of overtime will be required to facilitate the business needs.
Liaising with internal and external customers e.g. planning/ QA/ BU etc.
Carry out additional duties as deemed necessary by your Group Leader/ Supervisor.
Qualifications and Requirements
Desired Characteristics
Inclusion and Diversity
GE HealthCare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race color religion national or ethnic origin sex sexual orientation gender identity or expression age disability protected veteran status or other characteristics protected by law.
Behaviors
We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus and drive ownership always with unyielding integrity.
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 youd expect from an organization with global strength and scale and youll be surrounded by career opportunities in a culture that fosters care collaboration and support.
#LI-BG1
#LI-onsite
Additional Information
Relocation Assistance Provided: No
Required Experience:
IC
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