Mumbai, Maharashtra, India
None Not disclosed
On-site
Full Time
Experience - 5 to 12 Years Qualification- B.Pharm / Mpharm / B.Sc / M.Sc RESPONSIBILITIES R&D and commercial sourcing Source vendors for API, Excipient for new formulation project for regulated markets Documentation for ANDA filing, open part DMF from API vendors. Collect all the required documentation for initial evaluation from new/alternate vendor. Co-ordinate with Legal team to initiate CDA to disclose the confidential data open part DMF from outsource API vendors. Dossier extension to other market Co-ordinate with internal team (RA, Project management etc.) & arrange required documentation part from respective vendors for dossier extension and submission. Technical queries Arrange responses for open part DMF, technical queries & deficiencies wrt API, Excipient items. Procurement Arrange API, excipient for R&D to perform R&D development trial upto validation batches. Commercial procurement for finished dosage facilities. QA Documentation Arrange VQ & other documents of API & excipients to maintain AVL at plant level, dossier filing etc. DESIRED SKILLS Experience in R&D and commercial sourcing of API, excipient for new formulation projects of regulatory and ROW markets Good knowledge of regulatory documentation Fair Knowledge of Pharmaceutical Industry and its regulations Experience in SAP MM module Good communication skills Excellent negotiation skills and interpersonal skills Ability to work in a team environment. Willingness to work on diverse projects/areas. Proficient in word/excel and PowerPoint.
Mumbai, Maharashtra, India
None Not disclosed
On-site
Full Time
Experience- 1 to 3 Years Qualification- M.SC / B.SC RESPONSIBILITIES Manage the entire procurement cycle, from requisition to purchase order to payment, Ensure timely delivery of Intermediates, KSM & Solvents for API manufacturing facility. Collaborate with other departments, such as R&D, manufacturing, Supply chain, Stores, quality control & quality assurance to ensure smooth operations. Ensure compliance with relevant regulations and industry standards. Maintain accurate records of purchases, delivery information, and invoices, and preparing reports on purchases and cost analysis/monthly MIS. DESIRED SKILLS Knowledge of SAP MM is mandatory. Experience in Intermediates, KSM, Solvents procurement for API manufacturing facilities will be an added advantage. Excellent MS Office, advance excel and power point. Should have knowledge of logistics and import process. Very good communication and negotiation Skills. Should be willing to work in a dynamic environment.
Mumbai, Maharashtra, India
None Not disclosed
On-site
Full Time
Experience : 7-14 Years Qualification : B Pharm / M Pharm / B.Sc / M.Sc RESPONSIBILITIES Responsible for procuring intermediates, raw materials, chemicals, solvents, and impurities for various API manufacturing plants. Ensure import regulations. Focus on cost reduction through new vendor development and effective negotiations. Manage inventory in accordance with company policy to ensure smooth operations and meet business needs. Address and resolve issues related to product rejections, replacements, and arranging CAPA Oversee the liquidation of surplus inventory. Coordinate with the CQA team for audit scheduling and provide support with vendor documents. Assist the regulatory team by arranging necessary documents from vendors to respond to various inquiries. Work with the warehouse and planning team to ensure the timely delivery of materials based on business requirements. DESIRED SKILLS Must have experience in procuring intermediates, raw materials, chemicals, solvents, and impurities for various API manufacturing plants Must possess adequate knowledge of import regulations Good knowledge of regulatory documentation Excellent knowledge of Pharmaceutical Industry and its regulations Experience in SAP MM module Good communication skills Excellent negotiation skills and interpersonal skills Ability to work in a team environment. Willingness to work on diverse projects/areas. Proficient in word/excel and PowerPoint.
Bardez, Goa, India
None Not disclosed
On-site
Full Time
Experience- 18 to 20 Years RESPONSIBILITIES Review and approve change controls initiated by plants and send to CQA for approval. Review and approve vendor qualification documents and ensure effective implementation of the vendor approval system. Organize and execute internal audits at all plants and corporate departments as per the annual planner. Ensure audit reports and compliance reports with CAPA plan are prepared and implemented. Monitor and ensure that all plants comply with cGMP, cGLP requirements and good documentation practices. Review and approve of CQA guidelines. Update the CQA guidelines in line with the regulatory requirement. Review and approve SOP of Corporate departments. Review and approve of change controls, deviations, protocols and reports, qualification documents, stability protocols and MPR of corporate departments. Support plants for the review of regulatory compliance report and customer quality agreements as per requirements. Ensure that detailed investigations are in place for out of specifications, market complaints, product recall, and stability failures and that appropriate CAPA is planned and executed as per the defined procedures. Ensure that all team members are trained and updated in line with regulatory requirements. DESIRED SKILLS Should have adequate experience of facing various regulatory Inspections like USFDA, MHRA, EMA, TGA etc. Adequate experience of auditing finished dose formulation units, API and Intermediate/KSM vendors. Experience of working in Formulation unit as well as API unit would be preferred. Very good functional knowledge and application. Proactive approach to internal and external queries. Managing multiple stakeholders. Should hold high standards of business ethics. Excellent communication skills and decision-making skills.
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