QA Team Leader
7 months ago
Key Roles/Responsibilities:
- Compliance governance of key quality system elements, including scheduling and completion of; Quality Management Reviews, Qualification of Vendors, PQRs, Audits (Self-Inspections, Vendor Audits, Customer Audits).
- Maintain site establishment registrations with regulatory agencies as applicable.
- Manage updates to Drug Master Files and issuance of regulatory compliance reports
- Coordinate tracking of site compliance commitments and follow up actions. Coordinate and support the delivery of Quality Compliance Metrics/KPIs to key stakeholders.
- Identify GxP trends and communicate these to relevant stakeholders. Support compliance risk management activities and implementation of risk mitigation plans.
- Working with the wider site functions to drive down out of compliance events, identify and implement quality improvements
- Coordinate QMS training for site employees and ensure this adheres to current regulatory requirements
- Maintain responsibility as the site system owner for the Trackwise electronic QMS
- Support and track regulatory findings and trends that may lead into a focus of regulatory inspections
- Act as Single Point of Contact between site and Corporate Quality Team as delegated by QA Manager
- Assure compliance of procedures according to internal guidelines and UK/EU/US/ICH and other region specific guidance.
- Lead Quality Management Review meetings highlighting GxP areas of concern and working to support and track actions that are to be taken.
- Support quality related investigations, assist in the development and approval of effective CAPA in order to resolve product, audit and customer issues.
- Support effective pre-audit preparation, management and post audit follow up of customer audits and regulatory inspections.
- Escalate any significant breach of quality or regulatory compliance to the QA Manager (Compliance) and Head of Quality.
- Keep up to date and integrate current quality standards, guidelines and best practice on site. Ensure compliance by promoting understanding of the underlying concepts.
- Ensure productive working relationships are maintained between QA and other site personnel and stakeholders.
Competencies:
- Attention to detail
- Knowledge of GxP (GMP/GDP/GcLP/GCP) standards as applicable
- Detailed knowledge of UK/EU/ICH/FDA guidelines
- Risk based decision making skills
- Excellent communication skills and patient customer/ customer focus
- Ability to influence peers, senior managers and external parties
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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