Address Business: Piramal Pharma Solutions
Department: Quality
Location: Kurla, Mumbai
Travel: High
Job Overview
This position has responsibility for implementation / remediation of the systems, procedures and practices at the identified site(s) from a quality and compliance perspective.
Key Stakeholders: Internal
Site Quality Team, Site Head, Business Head, Corporate Functions
Key Stakeholders: External
Customers, Regulatory Auditors
Reporting Structure
Position will report to : Lead Technical Support and Quality Excellence
Experience :
- Need to be ready to live and embrace the Piramal values
- Quality professional with 10+ years of experience in a regulated pharma companies
- Experience in API. International Exposure
- Worked in USFDA, MHRA approved facility. Faced regulatory inspections
- Shall have good knowledge of QA operations
- Hands on experience implementing quality systems at site
- Well-organized, committed and result oriented professional, with strong verbal and written communication skills.
- Good Collaboration skills and Team player
- Passport is required. Candidates with valid US Visa preferred
Roles & Responsibilities :
- To understand the business & product needs with respect to system establishment and sustainability. In the process, it requires interactions with different sites and also assessing complexities of current processes.
- Deputation at manufacturing sites as QA team member.
- Perform site QA routine activities, Validation Activities, internal audit / gap assessment as per FDA 6 system and DI (Data Integrity). Lead remediation plan and restore compliance metrics at site.
- Prepare risk papers, position papers, conduct root cause analysis, propose and implement CAPA and risk mitigation plans for quality, compliance, existing business sustenance and business continuity.
- Work across all disciplines to ensure that the site maintains a state of readiness for inspection by regulatory agencies.
- Effectively track actions identified for restoring compliance at identified sites. Resolve the red flags and raise alerts timely.
- Identify quality requirements by reviewing regulations, guidelines, and standards, including USFDA, EU GMP, ICH and ISO. Keep abreast of changes to quality regulations and guidelines, advising the management team of any business implications of these changes. Lead, manage and ensure proper training to any relevant change management programs throughout the site / company.
- Represent Quality at senior management and review meetings.
- Responsible to follow the safety and environmental procedures deployed at Kurla office and sites.
- Coordinate with Corporate team for Corporate Initiatives and Long Term Quality Strategy.
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.
