Manager - Quality Control

Experience : Freshers
Location : Kottayam
Job Role : Others
Posted on 21 Jun 19
Job DescriptionLast Date 20 Aug 19
  • planning and leading a team for the execution of analytical method validation, method verification.
  • Ensuring that appropriate procedures and standards for the collection and preservation of analytical samples are adhered to; maintaining knowledge of state-of-the-art research techniques, technology, equipment, systems etc
  • lanning, delegating and coordinating work among team members on a day to day basis as well as for all projects.
  • To approve or reject, as he sees fit, starting materials, packaging materials, intermediate, bulk and finished products.
  • To ensure that all necessary testing is carried out and the associated records evaluated.
  • To approve specifications, sampling instructions ,test methods and other Quality Control procedures.
  • To approve and monitor any contract analyst lab ,if any.
  • Implementation of cGLP and ensuring compliance with respect to all activities of QC.
  • Planning and executing various analytical methods, Pharmaceutical Development System and New Drugs and Intermediates.
  • Analytical method validations – Preparation of protocols, and execution of Validation exercises and Preparing AMV reports.
  • Method development for the drug substances and finished products.
  • Product development reports review and technology transfer documents review.
  • On job training and Qualification of Analytical personnel, cGMP training.
  • Qualification of analytical instruments(DQ,IQ,OQ &PQ).
  • Preparation and Qualifications of working standards against pharmacopoeial reference standards.
  • Approving certificate of analysis and all relevant documents and supporting to regulatory queries and vendor qualification.
  • Giving Analytical support for new product development and support for new product process, drying and cleaning validation.
  • Developing and review for Adequacy of STPs, SOPs and Protocols for ongoing & new products and their analysis.
  • Ensuring water testing and environmental monitoring activities.
  • Responsible for 21CFR Part 11 compliance, Laboratory investigations/deviations, CCP,OOS & OOT and responsible for responding to the marketing complaints.
  • Stability Study commitment as per ICH to the Regulatory Authorities & Customer’s Requirements.
  • Effective review on documents related to Raw Materials, Working standard qualification, In process and Intermediates, Finished products, Stability documents, STP and SOP documents and also documents related to remaining QC activities.
  • To develop second line in QC and Microbiology.
  • To participate in self inspection programme of other cross functional departments.
  • To provide analytical support during water system validation and area qualification.
  • Implementation of safety and good housekeeping practices.
  • To ensure that the required initial and continuing training of his department personnel is carried out and adapted according to need.
  • To establish,validate and implement all quality control procedures.
  • To oversee the control of the reference and or retention samples of materials and products when applicable.
  • To ensure the correct labelling of containers of materials and products.
  • To ensure the monitoring of the stability of the products
  • To participate in the investigation of complaints related to the quality of the product.
Job Type : Full Time
Interview Type : Face to Face Interview
Company Description

Sance Laboratories Private Limited is located at Kozhuvanal, Kottayam District, Kerala, India and is a dedicated manufacturer of Cephalosporin range of antibiotic formulations in various dosage forms like Dry powder injections, Tablets, Capsules and Dry powder syrups.

The Sance Group is having an experience of more than 2 decades in pharmaceutical manufacturing. We have got a WHO GMP approved plant dedicated for cephalosporin antibiotic formulations with all modern facilities and automatic features. We are doing third party manufacturing for many MNC pharmaceutical companies and also for some of the big Indian Pharmaceutical Players. We are also marketing our products in India.