Role: Executive QA
Reporting To: Team Leader- QA
- Attend PTT meets and get all the requirements as per SOP and execute trial and validation batches
- Facilitate in transfering technology to other site or to SBPs through EMQA in order to manufacture the product at alternative site.
- Collect and provide documents required for DMF filing e.g. batch production records, specifications, stability data, certificate of analysis, impurity profile, process description and validation records to regulatory affairs team upon request; ;
- Coordinate with QC and production departments to get deficiency response for products;
- Prepare documents, statements and declarations related to animal origin absence, residual solvent absence, glutton free etc for different products in order to ensure that latest version of documents are sent to regulatory affairs team before DMF filing.
Customer Queries Resolution
- Collect information about product and plant to fill customer's questionnaire;
- Provide inputs to QC team for preparing new certificate of analysis in case of any change control and specification control;
- Interface between marketing and QC teams for any product related document;
- Respond to customer queries received through marketing by analyzing development reports;
- batch production records;
- validation reports, change controls record in order to provide all product related information to customers and other stakeholders within prescribed timelines.
Audits and Compliance
- Act as a single point of contact for other CTO QAs for all the products;
- Participate in deficiency resolution meeting with other stakeholders (QC, production , R&D, RA) ;
- Respond to the deficiencies based on available product data;
- Participate in bi-monthly meetings with RA team for exchange of information;
- Conduct internal audits (unannounced) for different departments in CTO;
- Conduct scheduled audits of different departments once in 3 months with cross functional team members;
- Assist during intra-department audits in order to ensure that all standard operating procedures are being complied with.
- Participate in quality related initiatives e.g. CPCPK and Lean manufacturing etc;
- Calculate and analyse data for process capability for different products and send it to corporate QA;
- participate in initiatives taken by corporate QA in order to ensure that customer is supplied highest order of quality products
Monograph evaluation and supporting to Regulatory
- Selecting of batches for Monograph evaluation and reviewing of evaluation report
- Supporting to RA in order to file DMF & to update and in responding queries in order to meet the pharmacopeial guidelines
Internal: QC Team, Marketing Team, RA Team, R & D team, Warehouse Team
Basic understanding of quality principles
Educational & Experience
Post-graduation in chemistry with minimum 2 years of experience in pharmaceutical industry
Technical knowledge of products, Quality control principles, Regulatory Guidelines, Good written Communication skills