Sr Manager/DGM – Manufacturing Sites & Technology | Glenmark Pharma | Indore, Aurangabad, Goa

Job Description

Roles and Responsibilities:

• To have experience in leading technical functions with a proven track record.
• Comprehensive understanding of scale-up, technology absorption, product transfer, process optimization, product robustness, and process performance qualification operations.
• Expertise to detect gaps in the manufacturing process, the potential for process improvements/optimization, and the ability to lead the team to ensure the resolution of technical issues in manufacturing, as well as to guarantee an adequate degree of process capability and process control for all products.
• In-depth understanding of equipment & facility qualifications, computer system validations, and cleaning validation
• To have hands-on experience in the Manufacturing Operation of OSD/Semisolid/Respiratory formulations and related equipment.
• Expertise in new product launches and commercialization
• Design and review protocols for scale-up and optimization, exhibit, pre-validation, process performance qualification, hold time studies, and investigation studies
• Create and review gap analysis reports, risk assessment reports, and other product- and CAPA-related reports.
• Review the revisions or change control of all essential process parameters, equipment, materials, facility to ensure impact analysis, accuracy, and compliance throughout the commercial life cycle.
• Lead/support manufacturing investigations relevant to OOS, OOT, and incidents as required, including data evaluation, root cause analysis, identification, and establishment of the root cause using a data-driven and scientific manner.
• Review the APQR and CPV (continuous process verification) reports, determine, support, and implement corrective measures, and interact with R&D as necessary for the enhancement of important quality attributes.
• Perform basic statistical evaluations (Running Chart, I-MR Chart, Box plot, Regression analysis, Cpk, and Ppk) of data and science-based and logical interpretation of data. Experience in Minitab/JMP software.
• Responding to internal as well as external audit observations with respect to manufacturing, process & validation-related deficiencies.
• Ensure technical training and development of the team of site manufacturing team concerning to CPPs, and improvement in mfg. process and process controls.
• Monitor the execution’s progress, seek early warning indicators, and take prompt action to ensure the project’s timely completion (filing timeline, launch timeline, commercial release timeline).
• Technical coordination with R&D/PDL/Production team for execution of Development/Exhibit/Process Validation batches/New Launches.
• Coordination with cross-functional teams and assistance in resolving problems encountered during batch production and investigation (as required), assessing timelines, and ensuring resolution as per the timelines.

Desired Candidate Profile

Educational Qualifications

M.Pharma

Experience:

18-20 Years