Chief Manager Quality Assurance | Piramal Pharma Solutions | Medak

Job Description

Job Overview:

The incumbent will be responsible for the overall smooth operation of QA activities in the plant on time within budget and within scope To oversee all aspects of QA, set deadlines, assign responsibilities to the team, ensure monitoring, summarize the progress of activities and prepare reports for top management regarding the status of activities To play key function between Production, QC, SCM, Technology Transfer, R&D and other cross-functional to achieve organizational goals

Key Responsibilities:

• Responsible for review and approval of all kinds of equipment qualifications.
• Responsible for review and approval of all AHU qualifications.
• Responsible for review and approval of all facility/area qualifications.
• Responsible for review and approval of computerized system validations.
• Responsible for review and approval of all utility qualifications.
• Responsible for review and approval of preventive maintenance schedule, Calibration schedule, and any other schedules related to the engineering department.
• Responsible for review and approval of cleaning validation activities.
• Responsible for review and approval of SOPs.
• Responsible for review and approval of change controls.
• Responsible for review and approval of investigation reports for Deviations.
• Responsible for review and approval of investigations for Quality Incidents.
• Review and approval of process validations. Responsible for IT compliance.
• Responsible for review of new project-related documents with respect to infrastructure and new manufacturing blocks.
• Responsible for review and periodical update of SMF & VMP.
• Responsible for review and approval of Temperature mapping-related documents.
• Responsible for review and approval of Quality Risk assessments.
• Responsible to provide the CAPA to the customers or regulatory audits for their observations related to the Engineering department.
• Responsible for auditing the Raw material and intermediate suppliers.
• Responsible to give the training on cGMP & SOPs.
• Responsible for improving the Quality Management System SOP as per the current regulatory standards.
• Responsible for the implementation of DI procedures at the site and ensuring compliance.
• Responsible to take care of Head QA activities in his absence.
• Coordinating customer audits and regulatory audits.
• Any other works allotted by the Head QA/Quality on day to day basis
• Responsible for activities of his manager in his manager’s absence

Qualifications:

• M.Sc (Chemistry)/ Mpharm preferred with about 15 20 years of experience in the Pharma Industry with 6 8 years in a managerial role.
• Knowledge of cGMP Norms, Quality policies, and procedures is preferred.

Experience:

• Minimum of about 15 years relevant experience, with exposure to senior management level in CRAMS, CDMO, and services-based development organizations.
• Proven working experience in Quality Assurance with increasing responsibilities in the domain, the field and must be familiar with a variety of the field’s concepts, practices, and procedures.
• Excellent client-facing and internal communication skills written and verbal.
• Solid organizational skills including attention to detail and multitasking skills
• Good team handling skills