Manager QA (CMO)

Manager Quality Assurance (CMO)

Role & responsibilities

• Develop, manage and improve quality systems and procedures to ensure compliance with regulatory standards in support of cGxP activities.
• Perform the gape assessment on regulatory guidelines and tracking of actions and its effective implementation at CMO/Althera affiliates.
• Responsible for review, approval and close out of change controls, deviations, CAPA, incident reports and any other quality related documents.
• Review and approvals of analytical and formulation development related master documents, protocols, and reports.
• Responsible for review and approvals of master documents (BMRs, BPRs, MFR, PVPs, PVRs etc.) and Protocols (Validation, Qualification, Cleaning, stability etc.)
• Overseas and monitoring of day-to-day activities in analytical development and formulation development (RnD site).
• Conducting training on SOPs, quality management systems and GMP in all aspects including procedural updates.
• Perform vendor audits of API and Excipients (where necessary) and handling of all activities related to vendor audits.
• Conduct periodic audit of CMOs and participate in the qualification programme as and when needed.
• Planning and conducting of self-inspection, preparation of schedule, execution with cross functional departments, and verifying the self-inspection compliance report for correctness and completion.
• Oversee, support and coordinate with the CMO/Althera affiliates on batches manufacturing and testing sites.
• Coordination with the European QA / RA team on supplying necessary quality documents as and when required.
• Responsible for CAPA monitoring, implementation, and its effectiveness at respective sites.
• Participate in the investigations at the manufacturing sites where necessary, review and ensure the investigations are conducted in line with the current regulatory expectations.
• Handling of customer complaints and to co-ordinate with the respective manufacturing sites to get the investigation done on timely manner with appropriate root causes and CAPA.
• Implementation of new softwares at contract manufacturing sites and sound knowledge on computer system validation.
• Coordinate with CMOs in any regulatory and customer audits at their site, track all the observations and the CAPAs are completed timely as per the commitment.
• Ensure quality / technical agreements with contract manufacturing organization (CMOs) are available and updated within timeline and its compliance.
• Review of NIRA and EIRA for the Althera products.

Preferred candidate profile

• Should have CMO experience with 12-15 years
• Should be M.Pharma
• Should have good experience in handling QA team at CMO with a strong background in managing

  CMO operations

  .
• Experience in

  formulations (OSD)

  , depending on product line.
• In-depth knowledge of

  GMP regulations

  ,

  regulatory guidelines

  , and

  quality systems

  .