Job description / Role
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.
Our client is one of the largest pharmaceutical manufacturers in the Middle East.
* 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.
* Responsible for CAPA implementation and monitoring its effectiveness.
* Define improvement plans and objectives that align to the Quality corporate strategy - the Operational Excellence Roadmap for QC Compliance.
* Conduct shop floor meetings / presentations, cascading down GMP / Quality relevant projects and initiatives to workforce.
* Identifying training needs of subordinates and evaluating the training outcomes in coordination with the concerned employees in the HR and Admin Department.
* Conducting performance appraisals for subordinates according to scheduled plans and recommending necessary actions as per the applied practices at the company.
* Following-up employee affairs including vacations, leaves etc. in coordination with HR and Admin Department.
Competitive salary + schooling + family flights and insurance
* 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 18 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
About the Company
Michael Page is one of the world's leading professional recruitment consultancies, specializing in the placement of candidates in permanent, contract, temporary and interim positions with clients around the world.
The Group has operations in the UK, Continental Europe, Asia-Pacific and the Americas. In the Middle East we focus on the areas of:
Finance & Accounting Banking & Financial Services Procurement Property & Construction Engineering & Supply Chain Oil & Gas Technical and Engineering Human Resources Sales Marketing Technology Secretarial Executive Search Legal
The Group operates through 161 offices in 33 countries and employs over 5,000 employees worldwide.
|Al Ain||18 Sep|
Quality Assurance Quality Control Engineer
A Leading Oil & Gas Company In UAE
Kinetic Business Solutions
|Abu Dhabi||21 Nov|
Quest Search & Selection