Chief Manager - Quality

Piramal Pharma Limited; Dahej; On-site; INR 2,400,000 - 3,600,000; Full time

Job summary

Piramal Pharma Limited's Piramal Critical Care division is seeking a Chief Manager - Quality to lead QA and QC at the site, ensuring cGMP compliance and robust quality systems. You will review documents, approve SOPs, batch records, change controls, conduct audits, and drive CAPA with risk mitigation.

The role requires coordinating with R&D support and external labs, while managing budget and training. Based in Dahej, Gujarat, this full-time position offers an opportunity to shape quality across

Responsibilities

• To ensure the effectiveness of quality management system at site.
• To review and approval of the all quality related documents like SOP’s, STP’s, validation protocol, stability protocol, batch records, qualification document, change control, deviation, OOS and others.
• To review the test report of in process, intermediates, raw material, finish product, packaging material, stability, validation and R&D.
• To ensure the manufacturing process is running with the cGMP compliance.
• Prepare risk papers, conduct root cause analysis, propose and implement CAPA and risk mitigation plans for quality and compliance.
• To perform vendor audit for existing as well as new raw material supplier.
• To perform audit for outside testing lab or calibration lab, as necessary.
• To maintain the QC/QA expenses within the budget.
• Monitors QA systems and upgrade the same as and when required, train other team members.
• To maintain the good coordination within department and interdepartmental by providing suggestion, solution w.r.t quality and compliance.
• To provide the regular training to all employee on site for awareness of cGMP compliance.
• To provide the support to R&D for new product development as well as analytical method development and validation.
• To investigate market complaint and its CAPA.
• Timely procurement of chemicals, reagents, instruments, service engineers to avoid break down of equipment and down time.
• Ensure that the quality assurance operational requirements are completed by scheduling and assigning employees; following up on work results.
• Maintain quality assurance staff job results by coaching, counseling, and disciplining employees; planning (KRA / goal setting), monitoring, and appraising job results.
• Report any incident/accident/ near miss/ illness to the superiors,
• Identify unsafe conditions and unsafe acts and report to superiors
• Any other job or responsibilities assigned by Head-Quality as and when required.

Job description

Division

Piramal Critical CarePiramal Critical Care (PCC), a business unit of Piramal Pharma, is the fourth-largest producer of inhaled anesthetics and a global player in hospital generics. We are motivated by our vision of commitment to delivering critical care solutions for patients and healthcare providers across the globe while achieving sustainable and profitable growth for all the stakeholders.

PCC maintains a wide presence across the US, Europe, and more than 100 countries across the globe. Its rich product portfolio includes Inhalation Anesthetics such as Sevoflurane, Isoflurane and Halothane as well as Intrathecal Baclofen therapy, for spasticity management.

PCC has a strong manufacturing and process development experience with wholly-owned, state-of-the-art manufacturing facilities in the United States and India, inspected periodically by the US FDA and the UK MHRA and other regulators. The strategic locations of our facilities help us supply high-quality products around the world, timely at optimal costs.

For more details, please visit https://www.piramalcriticalcare.com/global/

Job Title

Chief Manager - Quality

Job Description

Site quality head position leading both QA and QC functions

• To ensure the effectiveness of quality management system at site.
• To review and approval of the all quality related documents like SOP’s, STP’s, validation protocol, stability protocol, batch records, qualification document, change control, deviation, OOS and others.
• To review the test report of in process, intermediates, raw material, finish product, packaging material, stability, validation and R&D.
• To ensure the manufacturing process is running with the cGMP compliance.
• Prepare risk papers, conduct root cause analysis, propose and implement CAPA and risk mitigation plans for quality and compliance.
• To perform vendor audit for existing as well as new raw material supplier.
• To perform audit for outside testing lab or calibration lab, as necessary.
• To maintain the QC/QA expenses within the budget.
• Monitors QA systems and upgrade the same as and when required, train other team members.
• To maintain the good coordination within department and interdepartmental by providing suggestion, solution w.r.t quality and compliance.
• To provide the regular training to all employee on site for awareness of cGMP compliance.
• To provide the support to R&D for new product development as well as analytical method development and validation.
• To investigate market complaint and its CAPA.
• Timely procurement of chemicals, reagents, instruments, service engineers to avoid break down of equipment and down time.
• Ensure that the quality assurance operational requirements are completed by scheduling and assigning employees; following up on work results.
• Maintain quality assurance staff job results by coaching, counseling, and disciplining employees; planning (KRA / goal setting), monitoring, and appraising job results.
• Report any incident/accident/ near miss/ illness to the superiors,
• Identify unsafe conditions and unsafe acts and report to superiors
• Any other job or responsibilities assigned by Head-Quality as and when required.