Manager / Senior Manager - Quality (QA & QC)

Manager / Senior Manager - Quality (QA & QC)

1 Nos.
99683
Full Time
15.0 Year(s) To 25.0 Year(s)
20.00 LPA TO 35.00 LPA
Production / Quality / Maintenance
M.Sc / MS Science - Chemistry
Job Description:
  • Achieve quality assurance operational objectives by contributing information and analysis to strategic plans and reviews; preparing and completing action plans; implementing production, productivity, quality, and clients’ standards; identifying and resolving problems; completing audits; determining system improvements; implementing change.
  • Develop and maintain a Quality Management System in accordance with domestic and international medical device regulatory requirements (FDA, ISO13485, MDD, Health Canada, etc.)
  • Manage Quality Control related activities regarding all in-process checks, deviations, RM release, and finished product release. Ensure that products conform to specifications and regulatory requirements.
  • Approve or reject all formulations, procedures, specifications, test methods, raw materials, packaging materials, and finished products, including products manufactured at foreign sites, based on conformance / non-conformance to respective specifications that affect the purity, quality, and composition of each product.
  • Oversee complaint handling, corrective and preventive actions, internal audit program, supplier quality assurance, product inspection and release, equipment calibration, and control of nonconforming material.
  • Maintain and improve product quality by completing product and company system, compliance, and surveillance audits; investigating customer complaints; collaborating with other members of management to develop a new product, and manufacturing and training methods.
  • Prepare quality documentation and reports by collecting, analyzing, and summarizing information and trends including failed processes, stability studies, recalls, corrective actions, and re-validations.
  • Approve Raw Material Specifications before purchase. Develop Finished Product Specifications for existing & New Products.
  • Prepare a Certificate of Analysis for all clients, prepare Stability reports and Nutritional Facts for products.
  • Maintain Master formulations, Change Control, and history records. Develop & make a master formula for all new registrations. Identify and analyze issues related to in-process manufacturing and resolve them.
  • Review & maintain Work Orders and all related documents. Complaint handling: record all details about the complaint and prepare a complete investigation report, corresponding to the client till it’s resolved.
  • Communicating with clients and Laboratory for technical matters. Ensure that the contract laboratories are capable of performing all of the tasks and responsibilities assigned to them.
  • Review and verify test protocols, COA’s received from the third-party laboratory. Investigate OOS results received from the laboratory and find solutions.
Company Profile

--- --- --- is a Integrated and Innovative company, offering end-to-end solution to our customers globally. We are among world’s largest manufacturer and exporter of Dyes Intermediate, Dyestuff and Sulphuric Acid, with vertically and horizontally integrated who provides product solutions and service solution on fastest possible route to their customers.

--- --- --- having its presence not only in India but across the Globe and serving to 50+ countries with its Innovative products and services. It is coupled with our technical know-how, & expertise in manufacturing of Dyes Intermediate & other Specialty ---, our growth is propelled with the support of team members and management professionals, who work diligently to take the organization to newer heights year-on-year.

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