Quality Assurance Manager

Purpose

We are partnered with our growing pharmaceutical packing client, that is looking to expand their leadership team. This role is focused on the oversight and safety of their manufacturing activities in the respective section to ensure activities carried out are as per requirement of cGMP & safety to meet the quality and production targets in time.

We are partnered with our growing pharmaceutical packing client, that is looking to expand their leadership team. This role is focused on the oversight and safety of their manufacturing activities in the respective section to ensure activities carried out are as per requirement of cGMP & safety to meet the quality and production targets in time.

• Meeting priority demands during clashing equipment requirement in multiproduct facility. Overcome by efficient planning
• Keeping up with production schedule during facility renovation and equipment upgrade
• Utilization of capacity as per the production plan due to volatile demand. Overcome by rescheduling of plans
• More lead time for approval of regulatory documents by internal and external stakeholder Overcome by regular follow ups
• Unavailability of machine spares items because of limited budget. Overcome by maintaining the centralised control system for minimum stock of spare to be maintain all the time at stores for all identified machines.
• Long cycle time for variation approval or modification in batch manufacturing record due to delayed response by internal stake holder i.e. RA, R&D, LCM team and CQA, which can be overcome by defining the timelines for each stakeholder
• Issues in Quality of Raw Material i.e. lumps formation, presence of foreign material etc. Overcome by taking investigation and CAPA from the supplier

• Quality Assurance/Control for scheduling of batches, issues in product (Daily)
• Engineering & Utility for system related queries (Daily)
• Technical Support for troubleshooting in products (Case Basis)
• Technology Transfer for support in new products (Project Basis)
• Stores and Warehouse for RM/PM related activities (Daily)
• EHS for safety rounds and PPEs (Daily)
• Capacity panning, R&D, RA other manufacturing unit for Multiple formula harmonization and batch size optimization (Case basis).
• QA and CQA for preparation and implementation of SOP'S (Case Basis)
• IT for computerised system validation (Case Basis)
• Central SCADA Team for Real time process data-Acquisition and control (RTPD-AC) project way forward. (Fortnightly)
• Original equipment manufacturers for any operation related queries and for machine spare related queries (Monthly).
• External Auditors during facility audits (as per schedule)
• Equipment tooling suppliers for any tool related queries and updating the performance of the tools (Case Basis).
• Maintenance contractor for Instrument calibration scheduling and its execution (Monthly).
• Civil contractor for civil work (Case Basis)

Location:

Fall River, Massachusetts

Job Type: Permanent

Salary: $90, per year

Work Hours:

9 to 5

Education:

Bachelors

• Monitor and control planned production by daily activity review as per production plan to meet production targets and quality standards
• Review planned production vs. actual production daily and control the production activity of the plant as per the schedule
• Prepare production schedules for the block and ensure adherence to the schedules
• Ensure availability of raw materials, reagents and solvents during all shifts by verifying it with the forecasts
• Ensure execution of new product & product transfer by performing gap analysis to meet market requirements
• Review in-process analysis on daily basis to enhance the quality of final product
• Monitor unit operations and processes to avoid failures
• Ensure seamless communication and knowledge transfer of product in line across shifts for continuous production by participating in shift performance dialogue
• Ensure maintenance is carried out as per standards to realise optimum utilisation of manufacturing consumables
• Close maintenance issues by reviewing processes to meet production targets by coordinating with Engineering
• Optimise the utilisation of manufacturing consumables as per the budgets…