Location: Hyderabad
Position Overview: The SME - Pharma will play a critical role in overseeing and managing facility operations within pharmaceutical environments, ensuring adherence to industry regulations, standards, and best practices. This role requires deep knowledge of pharmaceutical facility management, regulatory requirements, and operational excellence.
Key Responsibilities
- Regulatory Compliance:
- Ensure that all facility management practices within pharmaceutical environments comply with Indian regulations, including but not limited to the Drug and Cosmetics Act, GMP (Good Manufacturing Practice) guidelines, and other relevant standards.
- Stay updated on changes in regulatory requirements and industry standards, implementing necessary changes in operations to maintain compliance.
- Facility Operations Oversight:
- Oversee the management of pharmaceutical facilities, including laboratories, manufacturing areas, and storage facilities, ensuring they operate efficiently and meet regulatory requirements.
- Implement and monitor SOPs (Standard Operating Procedures) to ensure consistency and adherence to industry standards.
- Quality Assurance:
- Develop and enforce quality assurance protocols to ensure that all facility management services meet or exceed pharmaceutical industry standards.
- Conduct regular audits and inspections to assess compliance and identify areas for improvement.
- Client and Stakeholder Interaction:
- Act as the primary point of contact for clients in the pharmaceutical sector, addressing their needs and concerns related to facility management.
- Collaborate with clients to develop and implement customized facility management
solutions that align with their operational and regulatory requirements.
- Training and Development:
- Provide training and guidance to facility management teams on pharmaceutical-specific regulations, standards, and best practices.
- Ensure that all team members are knowledgeable about compliance requirements and equipped to maintain high standards of operational excellence.
- Operational Excellence:
- Monitor and optimize operational processes to enhance efficiency, safety, and compliance within pharmaceutical facilities.
- Implement best practices and innovative solutions to address challenges and improve
overall facility management.
- Documentation and Reporting:
- Maintain accurate and up-to-date documentation related to regulatory compliance, facility operations, and quality assurance.
- Prepare and present regular reports to senior management and clients on compliance status, operational performance, and improvement initiatives.
- Risk Management:
- Identify potential risks related to facility management within pharmaceutical environments and develop strategies to mitigate these risks.
- Ensure that emergency preparedness and response plans are in place and regularly tested.
Qualifications
- Bachelor's degree in Pharmaceutical Sciences, Facilities Management, Engineering, or a related field; advanced degree preferred.
- Minimum of 10 years of experience in facility management within the pharmaceutical sector, with a strong understanding of regulatory requirements and industry standards.
- In-depth knowledge of Indian pharmaceutical regulations, including GMP, and the Drug and Cosmetics Act.
- Proven experience in managing pharmaceutical facilities and ensuring compliance with quality assurance standards.
- Strong analytical, problem-solving, and organizational skills.
- Excellent communication and interpersonal skills, with the ability to work effectively with clients, stakeholders, and team members.
- Proficiency in relevant software and technology platforms.
Skills: quality assurance,facility management (fm),drug policy,manufacturing,client interaction,organizational skills,training and development,medicine,proficiency in software technology,stakeholder interaction,interviewing subject matter experts,regulatory requirements,compliance,analytical skills,operational excellence,facility operations oversight,documentation and reporting,regulatory compliance,communication skills,technical compliance,regulations,interpersonal skills,risk management,problem-solving,pharmaceutical companies
