* 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.
* Reliability
* Effective communication
* Understanding of scientific and technical processes
Job Description
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
Qualifications
Essential Qualifications:-
Degree qualified in a Science Discipline is desirable.
Essential Experience:-
* Experience within a QC laboratory working to GMP within a recognised quality system.
* Ability to organise work within a busy laboratory with experience of writing and working to SOP documentation.
* Knowledge of GMP guidelines and regulatory bodies
About Us
In the three decades of its existence, Piramal Group has pursued a twin strategy of both organic and inorganic growth.
Driven by its core values, Piramal Group steadfastly pursues inclusive growth, while adhering to ethical and values-driven practices.
Equal employment opportunity
Piramal Group is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, ethnicity, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, genetics, or other applicable legally protected characteristics.
We base our employment decisions on merit considering qualifications, skills, performance, and achievements. We endeavor to ensure that all applicants and employees receive equal opportunity in personnel matters, including recruitment, selection, training, placement, promotion, demotion, compensation and benefits, transfers, terminations, and working conditions, including reasonable accommodation for qualified individuals with disabilities as well as individuals with needs related to their religious observance or practice.
About The Team
Piramal Pharma Solutions (PPS) is a Contract Development and Manufacturing Organization (CDMO) offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our customers through a globally integrated network of facilities in North America, Europe, and Asia. This enables us to offer a comprehensive range of services including drug discovery solutions, process & pharmaceutical development services, clinical trial supplies, commercial supply of APIs, and finished dosage forms. We also offer specialized services such as the development and manufacture of highly potent APIs, antibody-drug conjugations, sterile fill/finish, peptide products & services, and potent solid oral drug products. PPS also offers development and manufacturing services for biologics including vaccines, gene therapies, and monoclonal antibodies, made possible through Piramal Pharma Limited’s investment in Yapan Bio Private Limited. Our track record as a trusted service provider with experience across varied technologies makes us a partner of choice for innovators and generic companies worldwide.
Seniority level
* Seniority level
Entry level
Employment type
* Employment type
Full-time
Job function
* Job function
Quality Assurance
* Industries
Pharmaceutical Manufacturing
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