Inventia, established in 1985, is a privately held pharmaceutical development and manufacturing company based in Mumbai, India. Inventia is dedicated to developing complex generic and novel innovative pharmaceutical products, which have been instrumental in enhancing the product portfolio of our partners along with improvement in the patient's compliance and comfort. We partner with clients across the globe, which ranges from mid-sizes companies to large local players and multi-national companies. By working closely with our clients, we offer an end to end solution - right from research and development all the way to commercialization to support their expansion across emerging and regulated markets. Our state of the art Pharmaceutical and Technology centre is complemented by a world class production facility located at MIDC Ambernath. It is fully compliant with all international regulatory requirements. With an ever-growing portfolio of niche products, Inventia's presence has progressively increased to over 50 countries globally. By working closely with our clients, we believe in building and nurturing a long-term trusted relationship - with an aim to be their preferred development and manufacturing partner for any market.
Experience : 10-15yrs
Location : Thane
Qualifications : M.Pharm
- To follow Vendor Qualification procedure for Raw Material and Packaging Material.
- Leads vendor audits for supply of materials (RM, PM, Semi Finished goods) for commercial use.
- To prepare detailed audit reports for vendors andhighlight anydeviation from the pre- determined cGMP guidelines, Company, and Statutory requirements.
- Ensure compliance to audit observations and implementation of suitable action plans by the Vendor.
- To prepare vendor performance based on the feedback received from QA/QC Purchase
- &number of consignments received.
- Follow up the various documents required from the vendor. (E.g., Questionnaire, TSE/BSE free, Melamine free, Genotoxic free, Heavy Metal free certification, DMFopens part (need base), Stability data etc.)
- To initiate and execute deletion proposals for the Vendors.
- To update QM Info record in SAP for Raw/Packaging Material.
- To compile & review individual vendor file with all relevant documents in soft copy and update the same time to time.
- To update storage condition of raw materials and sampling criteria for Excipients in SAP
- To qualify the Contract Testing Laboratory by conducting audit.
- To prepare a Risk Assessment as applicable
- To approve packaging material specifications and code lists.
- To review the Regulatory Approval status of API vendors used in Regulated products.
- To ensure with FRD/ARD for the progress of suitability trial of API/Excipient fornew/alternate vendor.
- To participate in Self-audit program as an auditor and support as an auditeeduring respective audits within department.
