Senior Micro Analyst

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Job Description

Key Roles/Responsibilities:

• Execute and provide supervision and technical guidance and support for microbiology analysts performing environmental monitoring and testing of raw materials, in process products, bulk drug substance, final products and stability products, ensuring compliance according to defined SOPs, protocols and specifications.
• Provide technical and Subject Matter Expert support and guidance in microbiological techniques and processes.
• Ensure QC-Microbiology Analysts are appropriately trained and competent in the procedures they are conducting and are in compliance with best cGMP working practices at all times.
• Support introduction and validation/verification of new microbiological methods.
• Support preparation, technical review and approval of methods and analysis sheets for QC-microbiology.
• Perform technical review, assessment, approval and trending of Environmental Monitoring data.
• Support and ensure timely completion of microbiology related deviations, investigations and change controls.
• Co-ordinate microbiology testing to support batch release and stability testing timelines.
• Oversee completion of validation and qualification of new equipment and equipment periodic reviews within the department.
• Be accountable for the analytical laboratories being clean, tidy and well organised and in a state of continuous inspection readiness.
• SME support for client and regulatory audits/inspections and technical support for CAPA and procedural updates.
• Immediately escalate and report any deviations to materials, facilities, processes or procedures to the QC Manager.
• Participate in and support QC Microbiology department project and improvement activities.
• Conduct all activities in the most careful and safe manner and in full compliance with Quality/ESH requirements.
• Actively contribute to the development and maintenance of an enthusiastic, supportive and collaborative environment within the team setting.
• Undertake any other duties as requested by the line manager and 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 and investigation of deviations

Qualifications

Essential Qualifications:-

Degree qualified in a Science Discipline is desirable.

Essential Experience:-

Experience within a QC microbiology laboratory working to GMP within a recognised quality system. Experience managing a team of people. Ability to organise and schedule work within a busy laboratory with experience of writing and working to SOP documentation.

Extensive environmental monitoring and associated microbiology experience and knowledge. Experience and knowledge of GMP guidelines and working with 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.