Business Leadership \xe2\x80\xa2 Responsible to follow up the bulk and finished labs activities and suggest the appropriate actions \xe2\x80\xa2 Responsible for the overall supervision of chemical, physical, stability and finished laboratories for proper implementation and execution according to GLP. \xe2\x80\xa2 Inspects, investigates, and handles out of specification activities related to section. \xe2\x80\xa2 Follows and ensures GLP, GMP and safety procedures and maintain hygienic conditions in lab. \xe2\x80\xa2 Handles pharmaceutical textbooks, interpret monographs and search through different types of pharmacopeias. \xe2\x80\xa2 Maintains records and ensure proper documentation of the analysis; enter and check data on SAP. \xe2\x80\xa2 Coordinates with Assistant manager for better performance of the section. \xe2\x80\xa2 Communicates with R&D methodology section for smooth working and method transfer. \xe2\x80\xa2 Ensures training of new analysts or re-train the old ones for basic cGMP. \xe2\x80\xa2 Monitors and reviews quality related activities, coordinate work flow and communicate with different departments regarding quality control issues. \xe2\x80\xa2 Responsible for the responses for inspection requirements and handle quality related problems. \xe2\x80\xa2 Collaborate with R&D, Manufacturing, Validation and Engineering functions to drive Quality awareness, facilitate Good Manufacturing Practices and implement continuous improvement plans to ensure Product Quality Control and monitor department wise site KPIs. JOB DESCRIPTION \xe2\x80\xa2 Should act as Lead for the product QRMs and investigations including deviations/Market complaints/OOT, OOS/Product recalls and ensuring effective root cause analysis and assigning of appropriate CAPAs. \xe2\x80\xa2 Perform a periodic quality review on batch documentation. \xe2\x80\xa2 Responsible for product and facility changes assessment. \xe2\x80\xa2 Makes monthly plans and follow them. \xe2\x80\xa2 Writes, implements, and checks compliance of SOP\xe2\x80\x99s. \xe2\x80\xa2 Responsible for review and approval of product PQR reports. \xe2\x80\xa2 Responsible for review of product master documents not limited to Batch records, Specifications, Stability Reports, product validation reports. \xe2\x80\xa2 Prepare and review of Annual Product Quality Review reports. \xe2\x80\xa2 Participation in Internal and Regulatory audits and assure site readiness for the GMP audits \xe2\x80\xa2 Actively participate in continuous improvement initiatives. \xe2\x80\xa2 Arranges work for second and third shift & monitor staff performance \xe2\x80\xa2 Responsible for CAPA implementation and monitoring its effectiveness Strategic Leadership \xe2\x80\xa2 Define improvement plans and objectives that align to the Quality corporate strategy \xe2\x80\x93 the Operational Excellence Roadmap for QC Compliance \xe2\x80\xa2 Identify trends and determine system improvements to achieve GMP goals within the team. \xe2\x80\xa2 Continually assess current processes and their efficacy in addressing queries from both internal & external auditors \xe2\x80\xa2 Work with JTC to create robust system to build better deliverables against the Quality Culture & GMP sensitivity in everything that we do. \xe2\x80\xa2 Conduct shop floor meetings / presentations, cascading down GMP / Quality relevant projects and initiatives to workforce. \xe2\x80\xa2 Review current processes to identify issues, design and conduct analyses, synthesize conclusions into recommendations, and help to implement required changes to gain competitive advantage over the peers. People Leadership \xe2\x80\xa2 Conducting performance appraisals for subordinates according to scheduled plans and recommending necessary actions as per the applied practices at the company \xe2\x80\xa2 Responsible for On-Job training and people development. \xe2\x80\xa2 Controls productivity & gets maximum output with required man power utilization. \xe2\x80\xa2 Deliver proactive and effective communication related to improvement initiatives. \xe2\x80\xa2 Maintain and promote a teamwork environment with effective and clear communication amongst co-workers \xe2\x80\xa2 Identifying training needs of subordinates and evaluating the training outcomes in coordination with the concerned employees in the HR and Admin Department \xe2\x80\xa2 Following-up employee affairs including vacations, leaves \xe2\x80\xa6etc. in coordination with HR and Admin Department. JOB DESCRIPTION Core Competency \xe2\x80\xa2 In terms of competency you are highly result oriented with strong sense of accountability & ownership. \xe2\x80\xa2 High on communication and collaboration, having an ability to manage multiple stakeholders \xe2\x80\xa2 Must be able to manage tasks and priorities and easily adapt to changing situations. \xe2\x80\xa2 Good command in English (Communicating, writing and speaking) \xe2\x80\xa2 Self-motivated and enjoy working as part of a supportive team. \xe2\x80\xa2 Effective oral and written communication skills. \xe2\x80\xa2 Hard working, high on learning agility and change readiness \xe2\x80\xa2 Enthusiastic, flexible, and versatile approach to work \xe2\x80\xa2 Proficient in Computer Applications. \xe2\x80\xa2 KPI management, proven experience in conducting Risk Assessments. \xe2\x80\xa2 Problem Solving and high agility on taking right scientific decisions

Required Skills quality and excellence, Regulatory Compliance, GLP, GMP, QOO

Job Requirements In terms of competency you are highly result oriented with strong sense of accountability & ownership. \xe2\x80\xa2 High on communication and collaboration, having an ability to manage multiple stakeholders \xe2\x80\xa2 Must be able to manage tasks and priorities and easily adapt to changing situations. \xe2\x80\xa2 Good command in English (Communicating, writing and speaking) \xe2\x80\xa2 Self-motivated and enjoy working as part of a supportive team. \xe2\x80\xa2 Effective oral and written communication skills. \xe2\x80\xa2 Hard working, high on learning agility and change readiness \xe2\x80\xa2 Enthusiastic, flexible, and versatile approach to work \xe2\x80\xa2 Proficient in Computer Applications. \xe2\x80\xa2 KPI management, proven experience in conducting Risk Assessments. \xe2\x80\xa2 Problem Solving and high agility on taking right scientific decisions

Qualification Bachelor\'s degree or Master\'s degree is preferred in Pharmacy as preferable or equivalent field plus experience in Chemistry and Microbiology Dept. \xe2\x80\xa2 MBA or MS in Quality Management a plus \xe2\x80\xa2 At least 20 +years\' experience in pharmaceutical industry including experience in handling Quality Control Department in managerial level. \xe2\x80\xa2 Has previous experience in a similar role for better fitment \xe2\x80\xa2 Departmental budgeting and basic finance knowledge is desirable \xe2\x80\xa2 Having progressive experience in the Quality Control, and integration with R&D , supporting commercial registered product operations, having GMP approval from highly regulated authorities (HRAs) USFDA/MHRA/EU/TGA. \xe2\x80\xa2 Solid track-record in Managing Quality System and handling FDA\'s inspections \xe2\x80\xa2 Must be highly organized, self-motivated and experience in building or updating quality system for Pharmaceuticals

Sep 19, 2023

20 - 30 Years Exp.

1 Vacancy

Archer & Bull