Assoc Dir Quality Control

Job Description:

Responsibilities

•  Quality Control Laboratory
• Handling all the Quality Control Laboratory operations in compliance with Good Laboratory Practices and Safety policies.
• Selection, upgradation, procurement, installation and qualification of laboratory instruments and equipment.
• Preparing and monitoring of Capex and Revenue budget for laboratory.
• Preparation and execution of cost improvement plans for the laboratory expenses.
• To identify the needs and to provide resources, adequate facility required for effective and efficient functioning of the department for timely analysis of samples.
•  Quality Management
• Oversees the implementation of Standard Operating Procedures relating to the laboratory activities and compliance with the requirements of Good Laboratory practices.
• Upgradation of laboratory systems as per the regulatory requirements.
• Oversees calibration and preventive maintenance of laboratory instruments and equipment as per schedule, in accordance with approved Standard Operating Procedures. To arrange vendor assistance for AMC and other Instrument/ equipment breakdown.
• To ensure upkeep and maintenance of all laboratory standards as per written procedures and to arrange the Laboratory standards based on forecast and priorities.
• Responsible for monitoring the activities pertaining to upkeep and maintenance of Narcotics and controlled substances.
•  Stability Study
• To ensure identification, tracking and Co-ordination of all stability batches packed at Goa site and at other approved packing site.
• Responsible for activities related to stability management.
• To ensure planning, supervision and review activities of Commercial Stability Study Samples, Hold Time study Sample, Temperature Excursion, and Thermal Cycling.
•  Documentation
• Responsible for review of Specifications, Test Methods, Analytical Worksheet, Analytical Method Transfer/Verification/validation Protocol and Reports and Standard Operating Procedure of the Quality Control department.
• Ensures review and approval of departmental and site documents.
•  Budget and Inventory Management
• Ensure timely submission and monitoring of QC laboratory Capex budget.
• Initiation of Capital Expenditure Request as per agreed Quarter to match cash flow and procurement of budgeted items.
• Ensure completion of Unbudgeted Capital Expenditure Request as per requirement.
• Capex assets and inventory management in co-ordination with Finance department.
•  Inspections/Audits
• Participates in the self-inspection program conducted by the Quality Assurance Department.
• Ensures Audit readiness of Quality Control Laboratory and to face all regulatory and customer inspections and ensure compliance.
• Active participation in regulatory Audits, customer audits and compliance.
•  Data Integrity
• To ensure compliance to the requirements of policy and procedures on Data Integrity.
• To ensure that the GxP data handling is secure and adopt measures to ensure data Integrity.
•  To make sure that the current systems and practices are challenged to guarantee that data integrity is maintained.
•  Operational Excellence

Qualification & Expeirence

• Bachelor or Master of Science / Pharmacy 
• 15 – 20 years of experience in the Pharmaceutical Industry handling QC operations