Roles and ResponsibilitiesManage regulatory affairs for API products, ensuring compliance with global regulations.Conduct vendor qualifications and manage impurity testing to ensure product quality.Develop and maintain documentation related to regulatory submissions, including CTDs and eCTDs.Collaborate with cross-functional teams to identify critical process parameters (CPPs) and implement changes as needed.Ensure timely submission of dossiers to regulatory authorities.

Key Responsibilities: Regulatory Submissions: Prepare and submit regulatory documents (e.g., INDs, NDAs, ANDAs, CTDs, etc.) to health authorities (FDA, EMA, etc.). Regulatory Compliance: Ensure compliance with all regulatory requirements for drug development, clinical trials, marketing, and post-market activities. Cross-Functional Collaboration: Work closely with RD, Quality Assurance, Marketing, and Manufacturing teams to ensure regulatory strategies align with business goals. Regulatory Strategy: Develop regulatory strategies for new product development, clinical trials, and lifecycle management. Regulatory Intelligence: Monitor regulatory changes, trends, and guidance documents to stay current with industry standards. Labeling and Documentation: Review and approve product labeling, packaging, and promotional materials for regulatory compliance. Risk Management: Assess and mitigate regulatory risks in the development and marketing of products. Agency Interactions: Communicate with regulatory agencies to resolve issues, respond to queries, and gain approvals. Technical Proficiency: Familiarity with regulatory software and document management systems.

Roles and ResponsibilitiesLead formulation development activities for pellet products, ensuring timely delivery of high-quality prototypes.Conduct research analysis to identify opportunities for product improvement and implement changes accordingly.Collaborate with cross-functional teams to develop new formulations that meet customer requirements.Ensure compliance with regulatory guidelines and company standards throughout the development process.Provide technical guidance to junior team members on formulation development best practices.

An experienced Human Resources (HR) Recruiter plays a pivotal role in attracting, evaluating, and securing top talent for an organization. Beyond the foundational responsibilities, seasoned HR Recruiters are expected to: Key Responsibilities: Strategic Recruitment Planning: Develop and implement comprehensive recruitment strategies aligned with organizational goals, ensuring a proactive approach to talent acquisition. Advanced Candidate Sourcing: Utilize a variety of sourcing methods, including social media platforms, professional networks, and industry events, to identify and engage passive candidates. Stakeholder Collaboration: Work closely with hiring managers and department heads to understand specific staffing needs, job requirements, and team dynamics, ensuring a tailored recruitment approach. Candidate Assessment and Selection: Conduct in-depth interviews, administer relevant assessments, and perform thorough background checks to evaluate candidates qualifications, experience, and cultural fit. Offer Negotiation and Onboarding: Extend job offers, negotiate terms, and facilitate a seamless onboarding process to ensure new hires are well-integrated into the organization. Data-Driven Reporting: Monitor and analyze key recruitment metrics, such as time-to-fill, cost-per-hire, and source of hire, to assess the effectiveness of recruitment strategies and make data-informed decisions. Employer Branding: Promote the organizations culture and values through various channels to attract high-quality candidates and enhance the companys reputation as an employer of choice. Qualifications and Skills: Experience: Proven track record of at least 2 years in HR recruitment or a related field, with a demonstrated ability to manage the full recruitment lifecycle. Education: Bachelor s degree in Human Resources Management, Organizational Psychology, Business Administration, or a related discipline. Technical Proficiency: Familiarity with Applicant Tracking Systems (ATS), resume databases, and recruitment software. Communication Skills: Exceptional verbal and written communication abilities, with strong interpersonal skills to effectively engage with candidates and stakeholders. Analytical Abilities: Strong problem-solving skills and the ability to analyze data to inform recruitment strategies. Certifications: Professional certifications in HR or recruitment (e.g., SHRM-CP, PHR) are advantageous. An experienced HR Recruiter is instrumental in building a strong workforce by ensuring the organization attracts, hires, and retains the most qualified individuals. Their expertise in strategic planning, candidate assessment, and stakeholder collaboration significantly contributes to the organizations success.

To follow cGMP ,safety norms and adhere with company policy Indenting the materials as per standard batch size and counter checking of the quantities before consumption/use Coordination with quality control, warehouse, floor level monitoring, execution of records where necessary Maintaining good housekeeping in the premises of organization The safety of the operations in the company as well instructions to maintenance department to attend breakdown maintenance and preventive maintenance Maintaining the quality of the product at all stages of manufacturing Handling of manufacturing reactions Maintaining of all the records concerned to production department Execution of online recording, Maintaining all records till the retention period Raising breakdown intimations Any other assignment related to manufacturing allocated by the department head.