Senior Manager MS&T
Abbott
Date: 3 weeks ago
City: Karachi
Contract type: Full time
Position: Senior Manager MS&T
Reporting to: Director MS&T – METAP CIS
Division: Established Pharmaceutical Division - Operation
Location: Karachi -Landhi Plant
Job Summary
The Senior Manager of MS&T is responsible for overseeing activities within their domain, which include executing technical projects, introducing new products and formulations, implementing continuous improvement (CI) initiatives, enhancing existing manufacturing processes, and ensuring compliance with cGMP standards. Additionally, they must monitor the R&D lab team's activities and ensure adherence to GXP regulations within the R&D lab area.
Major Responsibilities
Reporting to: Director MS&T – METAP CIS
Division: Established Pharmaceutical Division - Operation
Location: Karachi -Landhi Plant
Job Summary
The Senior Manager of MS&T is responsible for overseeing activities within their domain, which include executing technical projects, introducing new products and formulations, implementing continuous improvement (CI) initiatives, enhancing existing manufacturing processes, and ensuring compliance with cGMP standards. Additionally, they must monitor the R&D lab team's activities and ensure adherence to GXP regulations within the R&D lab area.
Major Responsibilities
- Responsible for all the activities taking place in R&D Lab and Responsible for technical problem resolution in R&D Lab
- Review of daily planning of R&D Lab (based on FIFO and priorities) considering attendance of the day. Also review the pending of the monthly projects
- Responsible for writing, implementation and updating Standard Operating Procedures (SOP) for all manufacturing equipment/system used in R&D Lab
- Periodic performance review of goals for current year against agreed upon goal and yearly review for all R&D group members for purpose of annual raises. Also discuss and set goals and growth plans for R&D staff for next year as per department/company strategies in annual PEx process
- Plan, implement and monitor training certification schedule for all R&D Lab member
- To provide help to subordinates in planning / organizing / leading and controlling activities, in their respective and assigned projects
- Technical support to affiliate for Continuous Improvement Projects when required
- Help R&D Lab, analytical section for validation/verification of analytical methods via manufacturing of product’s placebo and product trials
- Help affiliate to develop new vendor as per affiliate vendor approval procedure
- Help QC team for on-site audit request, risk assessment and other tasks related to new vendor approval (as required)
- To provide support to Analytical group for technical project
- Responsible for new product development, Bill of Material, Manufacturing Directions, standard Test Methods, Master manufacturing formula, Packaging Approval Note and trial lot manufacturing. Preparation and sending of Drug Code Request (DCR), First Lot Quality Review Package
- To check the Technical Packages prepared in R&D Lab, regarding Formula Change, Process Change and Method Development and Validation
- Pharm D/M Phil; preferably PhD in related field
- 10-15 years’ experience in the relevant field
- Knowledge of Documentation, Validation, Stability, Technical Problem Resolution, and other activities taking place in R&D Lab
- Good Communication and interpersonal skills
- Leadership Skills
- Product Development and Analytical Skills
- Proficient in MS Office
- Teamwork and problem-solving skills
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