Job Description

Job Summary/Main Purpose





The Quality Control Sr. Manager is supervisory in nature and will follow up the carry out inspection and analysis for different raw and packaging materials, bulk and semifinished products, finished products, usually through operation of different QC equipment. He will be requested to adhere with cGMP principles & ISO and to maintain them in an effective manner. He will use computer program that undertake handling & data entry.

The QC Manager is a subject matter expert in Technical knowledge with Pharmaceutical cGMP guidelines and should lead the issuance & review of the related documents (SOP, Protocols, Assessments, etc.)

The incumbent will support and manage the QC Function as well as leading the continuous improvements and managing various projects and should be able to define the quality priorities.


Key Responsibilities & Key Result Areas


Business Leadership


• Responsible to follow up the bulk and finished labs activities and suggest the appropriate actions
• Responsible for the overall supervision of chemical, physical, stability and finished laboratories for proper implementation and execution according to GLP.
• Inspects, investigates, and handles out of specification activities related to section.
• Follows and ensures GLP, GMP and safety procedures and maintain hygienic conditions in lab.
• Handles pharmaceutical textbooks, interpret monographs and search through different types of pharmacopeias.
• Maintains records and ensure proper documentation of the analysis; enter and check data on SAP.
• Coordinates with Assistant manager for better performance of the section.
• Communicates with R&D methodology section for smooth working and method transfer.
• Ensures training of new analysts or re-train the old ones for basic cGMP.
• Monitors and reviews quality related activities, coordinate work flow and communicate with different departments regarding quality control issues.
• Responsible for the responses for inspection requirements and handle quality related problems.
• 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.
• 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.
• Perform a periodic quality review on batch documentation.
• Responsible for product and facility changes assessment.
• Makes monthly plans and follow them.
• Writes, implements, and checks compliance of SOP's.
• Responsible for review and approval of product PQR reports.
• Responsible for review of product master documents not limited to Batch records, Specifications, Stability Reports, product validation reports.
• Prepare and review of Annual Product Quality Review reports.
• Participation in Internal and Regulatory audits and assure site readiness for the GMP audits
• Actively participate in continuous improvement initiatives.
• Arranges work for second and third shift & monitor staff performance
• Responsible for CAPA implementation and monitoring its effectiveness






Strategic Leadership




• Define improvement plans and objectives that align to the Quality corporate strategy - the Operational Excellence Roadmap for QC Compliance
• Identify trends and determine system improvements to achieve GMP goals within the team.
• Continually assess current processes and their efficacy in addressing queries from both internal & external auditors
• Work with JTC to create robust system to build better deliverables against the Quality Culture & GMP sensitivity in everything that we do.
• Conduct shop floor meetings / presentations, cascading down GMP / Quality relevant projects and initiatives to workforce.
• 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




• Conducting performance appraisals for subordinates according to scheduled plans and recommending necessary actions as per the applied practices at the company
• Responsible for On-Job training and people development.
• Controls productivity & gets maximum output with required man power utilization.
• Deliver proactive and effective communication related to improvement initiatives.
• Maintain and promote a teamwork environment with effective and clear communication amongst co-workers
• Identifying training needs of subordinates and evaluating the training outcomes in coordination with the concerned employees in the HR and Admin Department
• Following-up employee affairs including vacations, leaves ...etc. in coordination with HR and Admin Department.




Core Competency




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


Qualifications, Key Experiences / Functional Knowledge Requirements




• Bachelor's degree or Master's degree is preferred in Pharmacy as preferable or equivalent field plus experience in Chemistry and Microbiology Dept.
• MBA or MS in Quality Management a plus
• At least 20 +years' experience in pharmaceutical industry including experience in handling Quality Control Department in managerial level.
• Has previous experience in a similar role for better fitment
• Departmental budgeting and basic finance knowledge is desirable
• 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.
• Solid track-record in Managing Quality System and handling FDA's inspections
• Must be highly organized, self-motivated and experience in building or updating quality system for Pharmaceuticals