Job 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. Act as system owner of QC equipment, assisting in equipment periodic reviews, and monitoring and maintaining calibration status of equipment within the Quality Control department. Take ownership and accountability of deviations, investigations, and laboratory investigations, ensuring timely completion of these documents. Prepare and update SOPs, instructions, protocols, and other Quality Control documentation. Check and review data in compliance with Data Integrity requirements. Actively contribute to department and site audit readiness requirements, including any continuous improvement initiatives. Calibrate equipment and instruments used to perform QC testing, and inform relevant personnel in a timely manner of any failure of calibration. Maintain Quality Control information systems. Maintain technical ability, knowledge, and understanding of relevant regulatory requirements for GMP, safety, and environmental policies required to perform the role of QC Analyst. Assist in the investigation of quality incidents and other problem-solving forums, completing QMS documentation in a timely manner. Attend internal and external scientific and technical meetings and conferences where appropriate. Carry out general maintenance and housekeeping of equipment and laboratories. Be available to provide cover for other departments within the organization as required. Undertake any other duties as requested by the QC Manager in accordance with Company requirements. Qualifications
Essential Qualifications: Degree qualified in a Science Discipline is desirable. Experience within a QC laboratory working to GMP within a recognized quality system. Ability to organize work within a busy laboratory with experience of writing and working to SOP documentation. Knowledge of GMP guidelines and regulatory bodies. About Us
Piramal Group has pursued a twin strategy of both organic and inorganic growth for three decades. 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, enabling 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. Job Info
Job Identification: 6820 Job Category: Quality Control Posting Date: 10/22/2024, 08:39 PM Job Schedule: Full time Location: Earls Road, Grangemouth, Stirlingshire, Falkirk, United Kingdom (County Level), FK3 8XG, GB
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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. Act as system owner of QC equipment, assisting in equipment periodic reviews, and monitoring and maintaining calibration status of equipment within the Quality Control department. Take ownership and accountability of deviations, investigations, and laboratory investigations, ensuring timely completion of these documents. Prepare and update SOPs, instructions, protocols, and other Quality Control documentation. Check and review data in compliance with Data Integrity requirements. Actively contribute to department and site audit readiness requirements, including any continuous improvement initiatives. Calibrate equipment and instruments used to perform QC testing, and inform relevant personnel in a timely manner of any failure of calibration. Maintain Quality Control information systems. Maintain technical ability, knowledge, and understanding of relevant regulatory requirements for GMP, safety, and environmental policies required to perform the role of QC Analyst. Assist in the investigation of quality incidents and other problem-solving forums, completing QMS documentation in a timely manner. Attend internal and external scientific and technical meetings and conferences where appropriate. Carry out general maintenance and housekeeping of equipment and laboratories. Be available to provide cover for other departments within the organization as required. Undertake any other duties as requested by the QC Manager in accordance with Company requirements. Qualifications
Essential Qualifications: Degree qualified in a Science Discipline is desirable. Experience within a QC laboratory working to GMP within a recognized quality system. Ability to organize work within a busy laboratory with experience of writing and working to SOP documentation. Knowledge of GMP guidelines and regulatory bodies. About Us
Piramal Group has pursued a twin strategy of both organic and inorganic growth for three decades. 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, enabling 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. Job Info
Job Identification: 6820 Job Category: Quality Control Posting Date: 10/22/2024, 08:39 PM Job Schedule: Full time Location: Earls Road, Grangemouth, Stirlingshire, Falkirk, United Kingdom (County Level), FK3 8XG, GB
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