Compliance Officer

at  Piramal Pharma Solutions

REQUIREMENTS:

• At least 5 years of controlled substance compliance experience working in a pharmaceutical or biologics manufacturing or distribution environment required
• Strong working knowledge of UK, European, GMP, GDP and WHO controlled substance regulations regarding the production, sales and distribution of narcotics. Global knowledge highly desirable.
• Ability to work independently with minimal supervision.
• Good communication skills, collaboration, and follow through.
• A University degree in management or life sciences preferred. Equivalent experience is acceptable.
• Computer skills: MS Office, Excel, PDF etc.
• Position requires attention to detail and ability to work as a team player interacting with multiple external sites
• Bachelor’s Degree in management or life sciences preferred
• SAP experience preferred.
• Languages: English (written and spoken), other languages such as German, French or Italian would be advantageous
• Diplomatic in contact with health authorities and their inspectors.
• Candidate should have strong knowledge on GS1 standards e.g. GTIN, NTIN, GLN, SGTIN
• Candidate should have knowledge on Country’s serialization regulatory requirement mainly FU FMD, India, USA, Russia and Saudi Arabia.

• Manage the submission, maintenance, and controlled substance filings for all EU PCC applications, licenses, and registrations. Update/remove drug codes and or drug schedules from licenses as required.
• Apply for all required import/export narcotics licenses in the EU and elsewhere as required.
• Maintain quotas of Controlled substances and proper accountability of all on-hand controlled substances.
• Prepare and manage controlled substance quota submissions.
• Liaise with all controlled substance regulatory authorities
• Prepare all required submissions and reports to appropriate regulatory agencies in a timely manner.
• Develop, monitor, and enforce appropriate procedures to prevent material diversion and ensure that all activities are controlled through approved procedures.
• Host regulatory controlled substance audits, follow-up of compliance and close out of audits
• Insure and audit 3PLs and transport companies for controlled substance regulation and procedure compliance.
• Review and audit Batch Manufacturing Records, Packaging and Supply documents for reconciliation purposes as required.
• Serve as the point of contact for PCC on matters involving controlled substances.
• Assist with the creation and standardization of a PCC Controlled Substance Program.
• Assist Sales in determining licenses required for new distributors/countries.
• Resolve or escalate any issues related to controlled substance products.
• Track & maintain a controlled substances inventory for compliance reporting; provide monthly reporting on performance measures and statistics; conduct audit checks of the controlled substances program and assess for continuous process improvements
• Track and complete all reporting requirements from all appropriate EU regulatory bodies including requests for controlled substance quota, completion reports, and theft or loss, and destruction reports;
• Conduct defined training sessions with employees responsible for direct handling of controlled substances in order to ensure their understanding of regulatory requirements;
• Organize and communicate the development of internal procedures pertinent to the handling of controlled substances in order to ensure compliance with Company requirements as well as local, state and federal regulations and laws
• Insure that business processes and conduct of PCC regarding production, storage, handling, sales and distribution of narcotics are compliant with the local and international regulations.
• Coordinate and manage the updates of the narcotic site license(s) addressed to the local health authorities regarding production, sales & distribution of narcotics.
• Conduct, lead and report out investigations involving controlled substances as required. Implement CAPAs and remediation plans on deviations as required.
• Stay informed about the modifications in regulations and expand knowledge in this discipline.
• Assure a good cooperation between the narcotic department and the health authorities.
• Need to work with QA and Logistics on any EMVO / NMVO reporting out activity and ensuring all shipment data is reported successfully before outbound shipments happen.
• Coordinate with the relevant Serialization team for both internal site and or CMO’s sites in case of failed EPCIS event posting and getting the issue resolved.
• Responsible for representing Serialization team in the EU region.