Search Results: 67 vacancies
...Manufacturing Organizations in advanced therapies are preferred.
Experience with hosting and/or supporting regulatory inspections (FDA, MHRA, EMA, etc).
Qualified as an Quality/GXP Auditor by a third party.
At Danaher we bring together science, technology and...
Suggested
Contract work
Work experience placement
Worldwide
...the job
~ Working knowledge of applicable GMP regulations, particularly 21 CFR Part 11, Eudralex Volume 4 Annex 11, and current FDA/MHRA guidance on Data Integrity
~ Expertise in all aspects of pharmaceutical GMP regulations (e.g. quality systems, root cause analysis...
Suggested
...CSV, Computer System Validation, Clinical Systems, Safety Systems, Infrastructure Qualification, 21 CFR part 11, GAMP 5, ICH, EMEA, MHRA regulations
Roles and Responsibilities
Must Have
We are looking for a pure validation resource with periodic review, audit experience...
Suggested
Permanent employment
Contract work
Remote job
...relevant regulations and guidances (e.g. 21 CFR parts 210, 211, 1271, 600, 601, 610, ICH Q10, EU GDP/GMP, Part 11/Annex 11, PIC/S, MHRA).
Strong written and verbal communication, analytical problem solving and conflict resolution skills.
Flexible, highly motivated...
Suggested
Temporary work
Work experience placement
Flexible hours
Shift work
...laboratory investigations (OOS, OOT, Atypical), deviations and associated CAPAs.
Proficient in application of FDA OOS Guidance, MHRA OOS Guidance and general QA principles, concepts, industry practices, and standards.
Proficient in Root Cause Analysis...
Suggested
Contract work
...state-of-the-art manufacturing facilities in the US and India that have successfully cleared periodical inspections by the US FDA, UK MHRA and other regulators.
Its core strength lies in a highly qualified global workforce of more than 400 employees across 16...
Suggested
Shift work
Weekend work
Day shift
...state-of-the-art manufacturing facilities in the US and India that have successfully cleared periodical inspections by the US FDA, UK MHRA and other regulators.
Its core strength lies in a highly qualified global workforce of more than 400 employees across 16...
Suggested
...engineering, quality and facilities within a pharmaceutical environment
* Knowledge of chemistry and microbiology
* Experience of FDA, MHRA and other regulatory pharmaceutical bodies
* Working knowledge of MS Project and managing cross functional projects
About the...
Suggested
Worldwide
Flexible hours
...Day-to-Day Responsibilities:
Extensive knowledge of principles and practices of HIV/AIDS Program guidelines and the HRA, MHRA and HPD regulations and directives, as applicable to the Program. Ability to provide emergency intervention (as needed) to clients living...
Suggested
Hourly pay
Work from home
Flexible hours
...We provide comprehensive solutions for the health sciences industry from experts you can trust. Our team includes former FDA, EU and MHRA regulators as well as industry experts. We combine regulatory knowledge with industry best practices to provide our clients with...
Suggested
Home office
...communicate adjustments as needed
+ Follow all Good Documentation Practices and cGMPs to ensure compliance to applicable FDA guidelines and MHRA guidelines
+ All other duties as assigned;
**The Candidate**
+ This position is entry level with a Bachelors in a related field...
Suggested
Holiday work
Full time
Local area
Worldwide
Monday to Friday
...are timely and compliant. Follows all Good Documentation Practices and cGMPs to ensure compliance to applicable FDA guidelines and MHRA guidelines.
+ Respond and interact with internal and external clients in a professional and timely manner.
+ Other duties as assigned...
Suggested
Holiday work
Full time
Local area
Worldwide
Monday to Friday
...regulated industry preferably with GxP computer system validation experience.
~ Experience in cGMP's and 21 CFR Part 11 in an FDA, MHRA, EMA or other regulated environment.
~ Experience working through a highly matrixed organization to support and drive key...
Suggested
Holiday work
Permanent employment
Local area
Relocation package
2 days per week
3 days per week
...self-management and organizational skills.
+ Experience with government regulatory agency interaction, e.g., FDA Advisory Committee, MHRA inspection, and/or preparing presentations and providing written responses.
+ Experience leading cross-functional teams.
+...
Suggested
Holiday work
Temporary work
Local area
...pharmaceutical dosage forms and/or combination products desired.
~ Must have in-depth knowledge of global regulations including FDA, EMA, MHRA and PMDA guidelines and have a proven track record in implementing these guidelines in fast growing environments.
~ Experience in...
Suggested
Holiday work
Contract work
Flexible hours
...maintaining full compliance with FDA Quality System Regulations (21 CFR Part 820), all applicable International Standards (i.e. ISO 13485, MHRA GMPs, etc.) and BD policies/procedures. This position will be the lead Quality representative for a class 3 legal manufacturing site...
Remote job
Shift work
...care home, which includes all regulated services in HCC Care, and those visiting in a professional capacity, must be fully vaccinated (MHRA approved) by 11 November 2021.
****Additional Role Information:****
Chef -
****Vetting Requirements:****
This post is...
Permanent employment
Contract work
Local area
Flexible hours
...processing large amounts of information to make sound decisions in order to meet regulatory requirements of various agencies: FDA, EU, MHRA and internal/site KPIs. Must have a high degree of initiative to resolve problems, discuss and research actions to be taken,...
Local area
Shift work
...state-of-the-art manufacturing facilities in the US and India that have successfully cleared periodical inspections by the US FDA, UK MHRA and other regulators.
Its core strength lies in a highly qualified global workforce of more than 400 employees across 16...
Afternoon shift
...Institute of Health (NIH), International Conference on Harmonization (ICH) GCP,Medicines and Healthcare Products Regulatory Agency (MHRA), Therapeutic Products Directorate (TPD) or HealthCanada, etc.
* Strong desire to learn, seek out, and apply new knowledge, methods...
Holiday work
