Senior QC Analyst

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Job Description

Key Roles/Responsibilities:

• Execute analytical procedures, for testing of raw materials, in process products, bulk drug substance, final products and stability products according to defined by SOP's, and protocols and ensure that the QC team is in compliance with the same.
• Apply best cGMP work-practices and techniques to test and release raw materials, in process products, bulk drug substance, final products and stability products within specification
• Ensure that all QC analysts are appropriately trained and competent in the procedures they are conducting, and are in compliance with best cGMP working practices at all times.
• Conduct on-time reporting according to the defined and trained document management standards including review and verification of analytical data provided by the QC Analysts
• Immediately escalate and report any deviations to materials, facilities, processes or procedures to the QC Manager
• Be accountable for the analytical laboratories being clean, tidy and well organized and in a state of continuous inspection readiness.
• Conduct all activities in the most careful and safe manner and in full compliance with ESH requirements
• Ensure that at any time equipment, facilities and materials used in the area of responsibility comply with defined standards.
• Issue, manage and close-out deviations, change controls, OOS or SST investigations and CAPA's in a timely fashion
• Identify areas for continuous improvement and escalate those to the QC Manager.
• Actively contribute to the development and maintenance of an enthusiastic, supportive and collaborative environment within the team-setting.
• Support installation, qualification and periodic review of equipment.
• Support the transfer of new methods and techniques into Quality Control.
• To undertake any other duties as requested by the line manager in accordance with company requirements

Competencies:

• Highly organised
• Effective communication
• Ability to motivate and organise a small team
• Attention to detail
• Understanding of scientific and technical processes
• Problem solving
• Investigation of deviations

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 and schedule work within a busy laboratory with experience of writing and working to SOP documentation.

Environmental monitoring and associated microbiology knowledge would be advantageous

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.