Job Description

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• Perform site R& D routine activities, Validation Activities, and Internal audit/gap assessment as per FDA 6 system and DI (Data Integrity). Lead remediation plan and restore
• To understand the business & product needs to system establishment and sustainability. In the process, it requires interactions with different departments and assessing the complexities of current processes.
• Prepare risk papers, and position papers, conduct root cause analysis, propose and implement CAPA and risk mitigation plans for quality, compliance, existing business sustenance, and business continuity.
• Identify quality requirements by reviewing regulations, guidelines, and standards, including USFDA, EU GMP, ICH, ISO, FSSC 22000, ISO 45001 & HACCP. 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 for the R& D Department.
• Represent Quality at senior management and review meetings.
• Review / Distribution of Tech Transfer, CDS, and specifications from the R&D Dept & other customers.
• Review & updation of STPs & specifications as per the current pharmacopeias.
• Preparation and review of quality risk assessments.
• To review & approve SOPs, specifications, and test methods of the products.
• Review of calibration certificate (External/internal)
• Review & verification of Method validation, cleaning validation & process validation.
• All R& D related documents, records, audit trail, and raw data shall be reviewed.
• Preparation and updation of R&D departmental SOPs and loading it in DCS (Document Control System) ENSUR 4.2
• Review of Change control, deviation, incident, CAPA, OOS, OOT & market complaint.
• Ensuring the quality and integrity of all GXP data and documentation generated.
• Ensuring effective execution requirements of food regulations (US)-21 CFR Part 111.
• Ensure the 21 CFR Part 11 compliance in the Laboratory.
• To fulfill the analytical requirements of FSSAI regulation.
• Adherence to the requirements of EHS norms.
• To determine internal and external QEHS issues as well as needs and expectations of relevant interested parties and monitor the same.
• To implement QEHS policy & objectives.
• To ensure participation and consultation of workers.
• Ensure the use of PPE
• To identify & communicate incidents, QEHS nonconformities, investigate and take corrective actions on the same.
• To ensure the work permit system during maintenance activities.
• To implement QEHS continual improvement projects at the site and monitor.
• To ensure disposal of waste.
• Authorised to prevent improper workplace conditions.
• Authorised for reporting of Hazards, Incident, Accidents and Near miss reporting.
• Authorised to prepare OH&S performance document.
• Authorised to conduct training of workers related to OHSMS.


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.