Coral Drugs

Company: Coral Drugs. Pvt. Ltd. Workplace Type: Full – Time. Job Location: Gurugram, Haryana. Experience: 5+ Years. (Experience within API manufacturing companies is preferred) hrcdpl-4@coraldrugs.com or WhatsApp resume @8199986208

Posted: July 2025 Provide corporate-level oversight of quality systems across all manufacturing sites to ensure compliance with global regulatory standards (USFDA, EU-GMP, WHO-GMP, etc.). Drive implementation and harmonization of GMP practices and quality policies across sites, ensuring alignment with corporate quality objectives. Review and approve key quality documents such as Master Batch Manufacturing Records (BMRs), Validation Protocols, and SOPs at a corporate governance level. Lead the Vendor and Supplier Qualification Program – including audits, risk assessments, compliance tracking, and ongoing quality performance monitoring. Serve as the key quality liaison for external stakeholders – managing quality-related communications and expectations with both clients and regulatory bodies. Oversee management of critical quality systems including Change Control, Deviation Handling, CAPA, OOS/OOT investigations, and Complaint Management across all sites. Monitor and assess site-level audit compliance; escalate significant issues to executive management and guide resolution strategies. Support the preparation and hosting of regulatory inspections and client audits across sites, ensuring consistent corporate representation and follow-up. Author, review, and maintain Corporate QA SOPs, ensuring alignment with evolving regulatory expectations and industry best practices. Champion a culture of continuous improvement and compliance, mentoring site QA teams and facilitating quality training initiatives.

Corporate Quality Assurance (CQA) Sr. Executive Posted: July 2025 Coral Drugs Pvt. Ltd. is seeking a skilled and experienced professional for the role of Senior Executive / Assistant Manager Corporate Quality Assurance (CQA). This position is ideal for candidates with over 7 years of experience, particularly within the Active Pharmaceutical Ingredient (API) sector. The role involves document review, audit processes, quality compliance, and regulatory adherence to global standards such as USFDA, EU-GMP, and WHO-GMP. Read more and apply

Posted: July 2025 Role Overview This hybrid role supports Top-Level Management with high-impact executive support while managing cross-functional projects related to Regulatory Affairs , Quality Assurance , Capex Investments , Operations , and Strategic Planning . The ideal candidate is highly organized, discreet, and capable of following up across technical departments to ensure alignment and timely execution. Key Responsibilities Executive Assistant Manage calendars, travel, meetings, and follow-ups for top-level management Draft and format reports, presentations, business dashboards, and internal communications Handle confidential documentation and ensure timely coordination between departments Track strategic priorities and ensure visibility on open items across leadership Support planning and documentation for leadership reviews and planning sessions Project Manager – Technical Operations Track and coordinate multi-departmental projects involving: Regulatory – submissions, gap closures, document reviews Quality – CAPAs, SOP updates, audit preparation Capex – vendor tracking, installation milestones, and site coordination Operations – production schedules, cross-team dependencies Planning – Gantt charts, risk registers, dashboards, and deadline adherence Facilitate cross-functional communication and timely document exchange Maintain trackers and timelines for new initiatives and follow-up actions Assist in audit readiness and data/document coordination for external stakeholders Qualifications & Skills Bachelor’s degree in business, science, or related discipline 6–10 years of experience as an Executive Assistant, Project Coordinator, or similar role Proven ability to manage sensitive communications and support senior leadership Experience handling technical or regulated projects is a plus Excellent written communication, follow-up skills, and attention to detail Proficient with MS Office, Excel trackers, and project coordination tools

Posted: July 2025 Key Responsibilities Lead day‑to‑day purchasing operations across raw materials, solvents, intermediates, primary & secondary packaging, engineering spares, and capex items. Develop, qualify, and manage global supplier base; negotiate contracts for cost, quality, and compliance. Maintain robust vendor relationships and performance metrics; drive vendor development programs aligned with regulatory expectations. Monitor inventory (incl. Min‑Max for engineering & critical raw materials); ensure uninterrupted production support. Coordinate and manage Capex projects, site expansions, new machinery and part purchases. GMP / Compliance Expectations (API Focus) Ensure all materials suppliers are qualified per cGMP and ICH Q7 expectations for APIs (quality agreements, audits, change control). Maintain full traceability & data integrity (ALCOA/ALCOA+) across purchase specs, CoAs, logistics, and release status to support US FDA, EU GMP, and other agency inspections. Align incoming material controls for supplier reliability, and documentation retention. Qualifications & Skills Bachelor’s degree in Supply Chain Management, Business Administration, or related discipline. Deep experience in pharmaceutical / API manufacturing procurement; demonstrated understanding of cGMP supplier qualification & audit processes. Strong negotiation, cost analysis, and contract management capabilities supporting global regulatory compliance.

Posted: July 2025 Key Responsibilities Identify & develop new business opportunities for APIs in domestic and global markets; manage pipeline and lead conversion. Conduct market research—trends, competitor landscape, customer requirements—to inform pricing & portfolio strategy. Build and nurture strong relationships with current and prospective customers; deliver product proposals and commercial presentations. Coordinate cross‑functionally (Regulatory, R&D, Production, Quality, Stores, etc.) to deliver samples, technical / regulatory documentation (DMFs, CoAs, stability data as applicable), and commercial supplies on schedule. Support customer qualification visits, audits, and due‑diligence activities; capture and drive closure of action items. Negotiate commercial terms (pricing, supply, contracts) with guidance from senior leadership. Track sales KPIs, forecast demand, and prepare management reports. Represent Coral Drugs at trade shows, exhibitions, and industry conferences., domestically and internationally. GMP / Compliance & Customer‑Facing Technical Support Understand global regulatory expectations (ICH Q7, US FDA cGMP, EU GMP Part II) to communicate site capabilities, dossier status, and compliance posture to customers. Facilitate audit readiness information flow between customers and internal Quality/Regulatory teams; escalate compliance‑critical feedback promptly. Qualifications & Skills Bachelor’s degree (science, pharmacy, business, or related) required. 5+ years’ experience in API sales / business development or related pharma B2B environment. Strong commercial acumen with ability to translate technical & regulatory data into customer value propositions. Comfortable engaging during customer GMP audits and responding to technical / quality queries with cross‑functional support.

Asst. Manager / Dy. Manager Pharma Sales & Marketing (International Marketing, APIs) Posted: July 2025 Grow global API sales for a multi regulator approved manufacturer: develop new domestic & international business, manage key accounts, coordinate samples/docs across Regulatory, R&D & Operations, and support customer audits in a highly regulated cGMP/ICH Q7 environment.

Support top-level management while driving cross-functional project execution across Regulatory, Quality, Capex, Operations, and Strategic Planning in a high-compliance API manufacturing environment. Ideal for someone organized, analytical, and experienced in regulated pharma settings.

Purchase Manager / Sr. Manager (Pharmaceutical API Manufacturing) Posted: July 2025 Drive end to end strategic procurement for a multi regulator approved API manufacturer own raw materials, solvents, intermediates, packaging, capex, and vendor development while ensuring cGMP/ICH Q7 aligned supplier qualification, compliant documentation, and inventory control that supports global regulatory readiness (US FDA / EU GMP / Indian approvals)

As the Purchasing Manager at our company, you will be responsible for leading the day-to-day purchasing operations of various categories including raw materials, solvents, intermediates, packaging materials, engineering spares, and capex items. Your role will involve developing, qualifying, and managing a global supplier base, while negotiating contracts for cost, quality, and compliance. It is essential to maintain strong vendor relationships, monitor inventory levels, and coordinate capex projects, site expansions, and new machinery purchases to ensure uninterrupted production support. In this role, you will be expected to ensure that all materials suppliers meet the cGMP and ICH Q7 standards for APIs. This includes establishing quality agreements, conducting audits, and managing change control processes. Maintaining full traceability and data integrity across purchase specifications, Certificates of Analysis (CoAs), logistics, and release status will be crucial to support regulatory inspections by agencies such as the US FDA and EU GMP. Your responsibilities will also include aligning incoming material controls to ensure supplier reliability and proper documentation retention. To qualify for this position, you should hold a Bachelor's degree in Supply Chain Management, Business Administration, or a related discipline. Additionally, you must have extensive experience in procurement within the pharmaceutical or API manufacturing industry, with a strong understanding of cGMP supplier qualification and audit processes. Your skill set should include proficiency in negotiation, cost analysis, and contract management to ensure compliance with global regulatory standards. If you are a highly motivated individual with a proven track record in pharmaceutical procurement and regulatory compliance, and possess the necessary qualifications and skills outlined above, we encourage you to apply for this challenging and rewarding position as our Purchasing Manager.,

You will be responsible for identifying and developing new business opportunities for APIs in both domestic and global markets. This includes managing the pipeline and converting leads efficiently. Your role will involve conducting thorough market research to stay updated on trends, competitor landscape, and customer requirements, which will be crucial for informing pricing and portfolio strategies. Building and nurturing strong relationships with current and potential customers will be a key aspect of your job. You will also be expected to deliver product proposals and commercial presentations. Collaboration with various departments such as Regulatory, R&D, Production, Quality, and Stores will be essential to ensure the timely delivery of samples, technical/regulatory documentation, and commercial supplies. Supporting customer qualification visits, audits, and due diligence activities will be a part of your responsibilities. This will involve capturing and driving closure of action items. You will also be involved in negotiating commercial terms including pricing, supply, and contracts with the guidance of senior leadership. Tracking sales Key Performance Indicators (KPIs), forecasting demand, and preparing management reports will be important tasks. Additionally, you will represent the company at trade shows, exhibitions, and industry conferences both domestically and internationally. In terms of GMP/Compliance and Customer-Facing Technical Support, you will need to have a good understanding of global regulatory expectations such as ICH Q7, US FDA cGMP, and EU GMP Part II. This knowledge will help you communicate site capabilities, dossier status, and compliance posture to customers effectively. You will also play a role in facilitating audit readiness information flow between customers and internal Quality/Regulatory teams, promptly escalating compliance-critical feedback. To excel in this role, you should hold a Bachelor's degree in science, pharmacy, business, or a related field. A minimum of 5 years of experience in API sales/business development or a related pharma B2B environment is required. Strong commercial acumen and the ability to translate technical and regulatory data into customer value propositions will be essential. You should also be comfortable engaging during customer GMP audits and responding to technical/quality queries with cross-functional support.,