Qc Team Leader
7 months ago
**Key Roles/Responsibilities**:
- Be the Subject Matter Expert (SME) for all QC Stability activities.
- Manage stability study protocols (SSP) and analytical procedures, for stability testing according to defined by SOPs, and ensure that the QC stability team is in compliance with the same.
- Ensure that all QC Analysts, QC Technicians are appropriately trained and competent in the procedures they are conducting, and are in compliance with best cGMP working practices at all times.
- Ensure subcontract of QC testing and dispatching to approved suppliers is performed according to defined procedures and in compliance with GMP.
- Manage on-time reporting according to the defined and trained document management standards including review and verification of analytical data provided by Senior QC Analysts and QC Analysts
- Immediately escalate and report any deviations to QC Management.
- Be accountable for testing 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 CAPAs in a timely fashion
- Identify areas for continuous improvement and escalate those to QC Management
- Actively contribute to the development and maintenance of an enthusiastic, supportive and collaborative environment within the team-setting.
- To undertake any other duties as requested by the line manager in accordance with company requirements.
**Competencies**:
- Highly organized
- Effective communication
- Ability to motivate and organise a team
- Attention to detail
- Understanding of scientific and technical processes
- Problem solving and investigation of deviations
- Ability to prioritise, provide updates to senior management
- Dealing with external and internal clients and meeting deadlines
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.
**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.
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