QC Analyst - Day
Piramal Group
Date: 1 week ago
City: Falkirk
Contract type: Full time
Key Roles and Responsibilities:-
- Perform batch disposition and stability activities in a proactive and timely manner which includes Quality Control testing and reporting of raw materials, in process, bulk drug substance, final products and
- stability products to GMP and in accordance with Annex 11 Computerised Systems and 21CFRpart11 Good
- Documentation Practices for Electronic Data.
- Perform stability study programme activities, storage of in process, and final products samples and retention sample management
- System owners of QC equipment, assisting in equipment periodic reviews, monitoring and maintaining calibration status of equipment within the Quality Control department.
- Ownership and accountability of deviations, investigations and laboratory investigations and timely completion of these documents
- Preparation and update of SOPs, instructions and protocols and other Quality Control documentation
- Checking and reviewing of data in compliance with Data Integrity requirements
- Actively contribute to department and site audit readiness requirements including any continuous improvement initiatives.
- Calibration of equipment and instruments used to perform QC testing and informing relevant personnel in a timely manner of any failure of calibration
- Maintain Quality Control information systems
- Maintain a technical ability, knowledge and understanding of relevant regulatory requirements for GMP, safety and environmental policies required in order to perform role as QC Analyst
- Assist in investigation of quality incidents and other problem solving forums and complete QMS documentation in a timely manner.
- Attend internal and external scientific and technical meetings and conferences where appropriate
- Carry out general maintenance and house keeping of equipment and laboratories
- Available to provide cover for other departments within the organisation as required
- Available to undertake any other duties as requested by the QC Manager in accordance with Company requirements.
Key Competencies:-
- Attention to detail
- Reliability
- Effective communication
- Understanding of scientific and technical processes
- Perform batch disposition and stability activities in a proactive and timely manner which includes Quality Control testing and reporting of raw materials, in process, bulk drug substance, final products and
- stability products to GMP and in accordance with Annex 11 Computerised Systems and 21CFRpart11 Good
- Documentation Practices for Electronic Data.
- Perform stability study programme activities, storage of in process, and final products samples and retention sample management
- System owners of QC equipment, assisting in equipment periodic reviews, monitoring and maintaining calibration status of equipment within the Quality Control department.
- Ownership and accountability of deviations, investigations and laboratory investigations and timely completion of these documents
- Preparation and update of SOPs, instructions and protocols and other Quality Control documentation
- Checking and reviewing of data in compliance with Data Integrity requirements
- Actively contribute to department and site audit readiness requirements including any continuous improvement initiatives.
- Calibration of equipment and instruments used to perform QC testing and informing relevant personnel in a timely manner of any failure of calibration
- Maintain Quality Control information systems
- Maintain a technical ability, knowledge and understanding of relevant regulatory requirements for GMP, safety and environmental policies required in order to perform role as QC Analyst
- Assist in investigation of quality incidents and other problem solving forums and complete QMS documentation in a timely manner.
- Attend internal and external scientific and technical meetings and conferences where appropriate
- Carry out general maintenance and house keeping of equipment and laboratories
- Available to provide cover for other departments within the organisation as required
- Available to undertake any other duties as requested by the QC Manager in accordance with Company requirements.
Key Competencies:-
- Attention to detail
- Reliability
- Effective communication
- Understanding of scientific and technical processes
How to apply
To apply for this job you need to authorize on our website. If you don't have an account yet, please register.
Post a resumeSimilar jobs
Learning And Teaching Administrator
s1jobs,
Falkirk
£22,000
-
£27,000
per year
1 week ago
Post DetailsFull timeOpen endedThe closing date for applications is midnight on 14 November 2024.There is an expectation that work will be undertaken in the UK.This role is not eligible for sponsorship. Applicants require to have existing right to work in the UK.The University of Stirling recognises that a diverse workforce benefits and enriches the work, learning and research experiences of...
Dual Fuel Smart Meter Engineer
Ganymede,
Falkirk
£36,398
-
£38,398
per year
3 weeks ago
Dual Fuel EngineerAnd we grow again! Ganymede Energy are looking to grow our smart home workforce and are seeking safety-focused Dual Fuel engineers to become a part of our growing business.With an industry leading operational support team combined with industry leading high-tech equipment, localised working regions, opportunities to upskill in the future to EV & PV so you can benefit...
Youth Worker
Go! Youth Trust,
Falkirk
4 weeks ago
Go Youth Trust have an amazing management opportunity for the right candidate to join us during a period of growth. We seek a highly gifted, motivated and experienced Youth Work professional, with proven leadership and management capability, to be the key point of contact for young people engaging with our Propel programme. Propel is a brand-new programme which Go! Youth...
