Unichem Laboratories Limited

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.

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.

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.

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.

Position- Executive / Sr. Executive - Planning (Formulations) Experience- 5 to 10 Years Qualification - B.Sc. / B. Pharm or M.Sc / M. Pharm RESPONSIBILITIES Assist in annual budget & analysis and monitor against actuals. Asist on S&OP (sales & operations planning) process. Align production schedules for three formulation plants based in India. Ensure smooth supplies. Monthly resource verification execution done based on plan for formulation plants. Analysis of production planning based on open orders. Be part of ‘At Risk’ meeting with US team to ensure reduction in numbers of product in At Risk. Work out a plan based on priority to reduce air shipments. Monitor production and despatches on daily basis with respect the plan. Doing PO reconciliation with customers. Getting MOD from US and sharing with the plant and ensuring despatches. Monitor and achieve sales and customer demand for monthly/quarterly/yearly basis. Monitor project management for timely tech transfer, launch, and commercialization of the products in various markets. Generation and circulation of fortnightly sales reports Tracking of manufacturing against line plan. Giving Captive API requirements to API team for planning. Also tracking of API despatches to Captive as per shared schedule. Continuous monitoring of Demand vs Forecast vs Actuals. Supervise material procurement based on demand received from various markets. Oversee the day-to-day operations in terms of materials planning, purchasing, manufacturing, release, dispatch & delivery. Develop and use a supply chain dashboard through Power BI Provide daily, weekly monthly MIS reports as and when required. DESIRED SKILLS Hands-on experience in handling planning and budgeting activities in formulation plant. Experience in manufacturing line plan for Solid oral & injectable. Knowledge of formulation manufacturing. Must have strong experience in SAP operation, Advance Excel Proactive approach to internal and external queries. Excellent coordination skills. Ability to pivot and try new approaches when faced with challenges. Should hold high standards of business ethics Optimize to handle complexity. Very Good communication skills.

Experience - 5- 11 Years Qualification- B. Pharm / M. Pharm RESPONSIBILITIES Author high- quality CMC documentation for US FDA submissions (Original ANDA/Deficiency responses/Post approval supplements/Annual reports) in accordance with latest guidances assuring technical congruency and regulatory compliance. Identify the required documentation for US regulatory submissions and negotiate the delivery of approved technical source documents in accordance with project timelines. Review and Identify content, quality and/or timeliness issues with source documents, or any other potential authoring issues proactively. Keep knowledge up to date with regard to regulatory guidelines and requirements in all global regions as well as for new technical trends. Co-ordination with stakeholders on a regular basis to extend all technical support required from regulatory perspective. Actively participate as a member by contributing to the regulatory strategy, identifying critical issues and lessons learned. DESIRED SKILLS Hands on experience on using eCTD software and attending e-publishing requirements throughout project lifecycle. Good technical knowledge, review skills and understanding of regulatory submissions. Strong knowledge of CTD /eCTD requirements for submission of dossiers. Ability to try new approaches when faced with challenges. Should have good analytical and learning attitude.

Experience- 20 to 25 years Qualification- M.Sc./ M. Pharma / B. Sc. / B Pharma Location- Pithampur RESPONSIBILITIES Ensure ‘All time Readiness’ for regulatory inspections by continuous monitoring of cGMP, GLP & Regulatory norms. Ensure that systems, equipment, personnel, processes, analytical methods, cleaning method, utilities, facility etc are qualified/validated as per requirement. Review and approve all master documents and records like SOP’s, VMP, various validation protocols / reports. Master Production Records (MPR’s), Batch Production Records (BPR’s), Stability Protocol / Reports, Quality / Technical Agreements / APQR etc. Ensure that document control and document retention is followed as per SOP Perform self-inspection as per cGMP requirements and promptly reply to all inspectional observations of audits done by external agencies, customers and CQA. Ensure that all committed compliances are completed within the committed timelines. Provide prompt support to regulatory affairs by providing required reviewed data in a timely manner Review and approve qualification protocols / reports (DQ/IQ/OQ/PQ) related to Quality Control instruments, manufacturing equipment, computerized systems, utilities etc Approve/Reject the Finished API as deemed fit after necessary quality review and analytical records review. Continuously improve the existing systems / procedures as per Quality System Guidelines issued by CQA and various international guidelines including ICH. Prepare, coordinate and execute training schedule related to cGMP, GLP and SOP. Ensure that all stability studies are carried out as per SOP/protocol and accordingly the shelf life of the marketed product is monitored on a continuous basis. Review, approve / reject and close all Change Control / Deviation / records and ensure that required Corrective / Preventive actions are executed as identified in the concerned record. Investigate Out of specification results, Market Complaints and deviations effectively, approve the CAPA and ensure that identified Corrective & Preventive actions are executed. Formalize a system for quality risk identification / categorization and its mitigation. Review and ensure that the preventive maintenance and calibration schedules are adhered to. DESIRED SKILLS Should have adequate experience of facing various regulatory Inspections like USFDA, MHRA, EMA, TGA etc. Adequate experience of auditing API and Intermediate / KSM vendors. Experience of working in 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.

Experience - 16 – 20 yrs Location - Pithampur Qualification- M.Sc./ M. Pharma / B. Sc. / B Pharma RESPONSIBILITIES Daily planning of analytical activities, resource management and work allocation. Plan and execute sampling and analysis for raw materials, packaging materials, intermediates & finished products. Review and /or Approval & Implementation of Standard operating procedure Review and /or Approval of Implementation analytical protocol and analytical reports Review and /or Approval of Qualification and calibration of Instruments. Investigating and review of Investigation related to Laboratory Events, OOS, OOT and Deviations. To ensure the QC related electronic data management compliance such as computer system validation, electronic data backup, storage and retrieval. Conduct induction training, on-the–job, annual training and analyst qualification to enhance analytical skills of quality control personnel. Procurement and inventory control of material and equipment required for QC activities. Review analytical activities related to process validation, cleaning validation and analytical method validation. Authorise to release of raw material, intermediate, stability samples and working standards in absence of QC Head through LIMS. Monitoring of non-routine Activities like stability study, working standard Management, calibration Management, Analytical Method Transfer / method Verification. Responsible person for all QC activities in absence of Head – QC. 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 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.

You should have a minimum of 5-11 years of experience in authoring high-quality CMC documentation for US FDA submissions, including Original ANDA/Deficiency responses/Post approval supplements/Annual reports. Your responsibilities will include identifying required documentation for US regulatory submissions, ensuring technical congruency and regulatory compliance, reviewing and identifying content issues with source documents, and keeping knowledge up to date with regulatory guidelines. You must have a B. Pharm/M. Pharm qualification and possess hands-on experience with eCTD software, as well as a strong understanding of CTD/eCTD requirements for submission of dossiers. Additionally, you should be proactive in identifying authoring issues, coordinating with stakeholders for technical support, and contributing to regulatory strategy and critical issue identification. Desired skills for this role include good technical knowledge, review skills, ability to try new approaches when faced with challenges, and a positive analytical and learning attitude. You will also be responsible for attending to e-publishing requirements throughout the project lifecycle and ensuring timely delivery of approved technical source documents in accordance with project timelines.,

You should have 16-20 years of experience in the pharmaceutical industry and be located in Pithampur. A degree in M.Sc./ M. Pharma / B. Sc. / B Pharma is required for this position. Your responsibilities will include daily planning of analytical activities, resource management, and work allocation. You will be responsible for planning and executing sampling and analysis for raw materials, packaging materials, intermediates, and finished products. You will review and/or approve the implementation of standard operating procedures, analytical protocols, and analytical reports. Additionally, you will review and/or approve the qualification and calibration of instruments. You will investigate and review laboratory events, out-of-specification (OOS) results, out-of-trend (OOT) results, and deviations. Ensuring compliance with QC-related electronic data management, such as computer system validation, electronic data backup, storage, and retrieval, will be part of your role. You will conduct training sessions to enhance the analytical skills of quality control personnel. Managing procurement and inventory control of materials and equipment required for QC activities will be essential. You will review analytical activities related to process validation, cleaning validation, and analytical method validation. You will have the authority to release raw materials, intermediates, stability samples, and working standards in the absence of the QC Head through the Laboratory Information Management System (LIMS). Monitoring non-routine activities such as stability studies, working standard management, calibration management, and analytical method transfer/verification will also be part of your responsibilities. You will be the responsible person for all QC activities in the absence of the Head QC. Desired skills for this position include experience in facing various regulatory inspections like USFDA, MHRA, EMA, and TGA. Experience in auditing finished dose formulation units, API and Intermediate/KSM vendors is preferred. Experience of working in an API unit is a plus. You should have excellent functional knowledge and application skills, a proactive approach to internal and external queries, and the ability to manage multiple stakeholders. High standards of business ethics, excellent communication skills, and strong decision-making skills are essential for this role.,

Experience : 7 to 9 years of experience in Pharmaceutical Company Qualification : B. Pharm / M.Sc. Responsibilities: Ensure continuous audit and inspection readiness of the Learning Management System (LMS) and training processes at the Goa site. Support Learning Administrators (LAs) in coordinating and executing training programs to achieve and maintain 100% training compliance across all functions. Lead and execute all CSV-related activities for the LMS to ensure compliance with regulatory and internal quality standards. Monitor, review, and maintain accurate and compliant quality documentation related to the LMS for all applicable sites. Monitor, review, and maintain accurate and compliant quality documentation related to the LMS for all applicable sites. Collaborating with Learning administrators and supporting them with quality and technical requirements. Liaise with LMS vendors and third-party service providers to resolve complex technical issues and ensure uninterrupted system functionality. Ensure alignment of site training processes with applicable regulatory guidelines and corporate quality standards. Provide support for various HR and administrative tasks as needed, demonstrating flexibility and cross-functional Design and develop engaging and effective training content for technical, regulatory/compliance, and soft skills programs. DESIRED SKILLS : Experience in administering, validating, and supporting Learning Management Systems (e.g., SuccessFactors). Aptitude for identifying training gaps and implementing corrective and preventive actions (CAPA) to close compliance or performance issues. Proficient with digital tools and platforms used for training delivery, documentation management, and system support. High precision in maintaining accurate records, managing training documentation, and ensuring ongoing compliance. Demonstrated ability to manage multiple responsibilities including HR functions, training coordination, and administrative support. Skilled in maintaining audit trails, managing SOPs and training records, and ensuring readiness for regulatory inspections. Hands-on experience working in regulated environments with exposure to audits (e.g., USFDA, WHO, MHRA, etc.). Capable of coordinating with external vendors for technical troubleshooting and support related to training systems. Experience in scheduling, tracking, and reporting training compliance metrics for large teams or across multiple departments. Ability to support employee onboarding and contribute to a continuous learning and development culture at the site. Excellent written and verbal communication skills for interacting with internal teams, auditors, vendors, and leadership.

Experience- 20 to 25 Years Qualification- B. Pharm/ M. Pharm RESPONSIBILITIES Ensure achievement of budgeted targets on a monthly and yearly basis. Ensure site is in state of compliance for multiple authorities’ inspections and guide / coordinate during inspections and local statutory authorities. Work out areas of improvement in product cost, engineering cost and implement the same. Create and maintain an environment of mutual trust, respect, and customer centricity. Build and maintain a high performing team and culture. Ensure manpower management and engagement. Brand ambassador of Unichem for any internal and external stakeholders at the plant. DESIRED SKILLS Excellent Experience in manufacturing formulations (Tablets & Capsules). Exposure in Managing and working with International Regulatory Authorities like MHRA, EU etc. is a must. Should have strategic, operational excellence, collaboration, and customer-centric mindset. Excellent experience in general management, team management, and networking Should have experience in budgeting and cost optimization. Should have functional knowledge of LEAN Aptitude for automation and use of technology. Should have experience of working in a matrix environment. Should be ready to work in a dynamic environment. Excellent negotiation skills and interpersonal skills Experience in Site Transfer, New Product Launch & Green field Project will be appreciable.

Position Overview :- Strategic and hands-on IT leader responsible for managing multi-site GxP-compliant IT operations, plant infrastructure in a regulated pharmaceutical environment. Acts as the SPOC for IT for site leadership, ensuring uptime, compliance, and driving impactful technology-led business enablement. Experience 9-14 Years in Pharma Plant IT Operations with audit exposure. Qualification B.E. / B.Tech / BCA / BCS or an equivalent qualification, combined with relevant pharma IT experience and skillset RESPONSIBILITIES GxP IT Operations & Compliance Ensure 100% uptime of GxP-critical systems and infrastructure. Maintain real-time audit readiness across all sites, manage SOP adherence, QMS notifications, CAPA closure, and periodic reviews. Enforce regulatory-compliant practices for user access control, data integrity, and electronic records. Collaborate with central SAP teams to align plant needs. IT Infrastructure & Security Management Oversee standardization, qualification, AMC, retirement, and reusability of IT assets. Implement robust IT security controls, patch management, and cybersecurity governance for both GxP and Non-GxP environments. Proactively identify and eliminate CSV bottlenecks affecting manufacturing continuity. Audit & Regulatory Readiness Act as audit-facing SPOC for IT during internal and external audits (MHRA, USFDA, WHO, etc.) as needed. Guide and mentor Site IT Leads to take SPOC responsibility at their respective sites, ensuring readiness and compliance. Lead pre-audit checks, documentation reviews, and post-audit CAPA implementation. Ensure full alignment of IT practices with 21 CFR Part 11, EU Annex 11, and data integrity guidelines. Project Delivery & Solution Implementation Lead IT solution implementation at plant level including POC, vendor coordination, and validation. Ensure IT GxP assets and integrations are CSV-validated and fully compliant with GxP requirements across all sites. Drive digital transformation and automation initiatives in quality and manufacturing. Team Leadership & Stakeholder Engagement Lead, coach, and upskill a 25+ member IT team (direct/indirect, L2 structure). Collaborate with cross-functional teams-Quality, Manufacturing, Engineering, and Projects. Conduct regular site leadership connects to align IT strategy with plant KPIs. IT Governance & AIOps Implement AIOps and predictive monitoring to enhance system reliability and automation. Define and track IT SLAs, KPIs, and compliance scorecards. Drive innovation while ensuring adherence to Unichem and IT Security / InfoSec standards. Value Addition: Proven success in enabling business continuity and audit compliance through IT solutions. Spearheaded SAP-integrated projects and AIOps implementation, reducing downtime and manual interventions. Delivered cross-site standardization of IT operations, ensuring cost savings and audit consistency. DESIRED SKILLS Deep knowledge of Pharma IT Compliance (GxP, CSV), plant automation systems, and IT infrastructure lifecycle. Extensive experience in managing GxP-compliant IT operations at manufacturing sites, with deep understanding of the computerized system validation (CSV) lifecycle and regulatory requirements. Excellent leadership, audit-facing, communication, and cross-functional stakeholder management skills. SAP certification & relevant IT certifications preferred. Strong technical knowledge of SAP systems and IT infrastructure components (networking & server administration). Experience in SAP HANA, SAP Fiori, or a similar technology is a plus. Excellent problem-solving, analytical, and troubleshooting skills. Strong attention to detail with a proactive approach to solving complex technical problems. Should have project management experience and familiarity with project management methodologies (Agile, Waterfall, etc.). Familiarity with security frameworks and best practices in both SAP and IT infrastructure management. Knowledge of system integration techniques between SAP and IT infrastructure. Strong communication skills and the ability to interact effectively with technical and non-technical stakeholders. Strong leadership and interpersonal skills, with the ability to motivate and manage a multidisciplinary team. Willingness to work on diverse projects / areas. Strategic thinker with a focus on both operational efficiency and business alignment. Strong understanding of cybersecurity principles in plant IT environments, with hands-on experience in monitoring, detecting, and responding to threats to ensure protection against potential cyberattacks. Ability to implement and maintain robust security controls for both IT and OT assets in compliance with regulatory and InfoSec standards.

As the Strategic and hands-on IT leader responsible for managing multi-site GxP-compliant IT operations and plant infrastructure in a regulated pharmaceutical environment, your role will be pivotal in ensuring uptime, compliance, and driving impactful technology-led business enablement. You will act as the Single Point of Contact (SPOC) for IT for site leadership, maintaining real-time audit readiness, enforcing regulatory-compliant practices, and collaborating with central SAP teams to align plant needs. With 9-14 years of experience in Pharma Plant IT Operations and audit exposure, along with a qualification in B.E. / B.Tech / BCA / BCS or an equivalent qualification, you will be expected to fulfill the following responsibilities: GxP IT Operations & Compliance: - Ensure 100% uptime of GxP-critical systems and infrastructure. - Maintain real-time audit readiness, manage SOP adherence, QMS notifications, CAPA closure, and periodic reviews. - Enforce regulatory-compliant practices for user access control, data integrity, and electronic records. - Collaborate with central SAP teams to align plant needs. IT Infrastructure & Security Management: - Oversee standardization, qualification, AMC, retirement, and reusability of IT assets. - Implement robust IT security controls, patch management, and cybersecurity governance. - Identify and eliminate CSV bottlenecks affecting manufacturing continuity. Audit & Regulatory Readiness: - Act as audit-facing SPOC for IT during internal and external audits. - Guide Site IT Leads to ensure readiness and compliance. - Lead pre-audit checks, documentation reviews, and post-audit CAPA implementation. - Ensure full alignment of IT practices with regulatory guidelines. Project Delivery & Solution Implementation: - Lead IT solution implementation at plant level. - Ensure IT assets and integrations are fully compliant with GxP requirements. - Drive digital transformation and automation initiatives. Team Leadership & Stakeholder Engagement: - Lead, coach, and upskill a 25+ member IT team. - Collaborate with Quality, Manufacturing, Engineering, and Projects teams. - Align IT strategy with plant KPIs. IT Governance & AIOps: - Implement AIOps and predictive monitoring for system reliability. - Define and track IT SLAs, KPIs, and compliance scorecards. - Drive innovation while ensuring adherence to IT Security standards. Value Addition: - Proven success in business continuity and audit compliance through IT solutions. - Spearheaded SAP-integrated projects and AIOps implementation. - Delivered cross-site standardization of IT operations. Desired Skills: - Deep knowledge of Pharma IT Compliance, plant automation systems, and IT infrastructure lifecycle. - Strong leadership, audit-facing, communication, and stakeholder management skills. - SAP certification & relevant IT certifications preferred. - Technical knowledge of SAP systems and IT infrastructure components. - Experience in SAP HANA, SAP Fiori, or similar technology is a plus. - Strong problem-solving, analytical, and troubleshooting skills. - Project management experience with familiarity in Agile and Waterfall methodologies. - Familiarity with security frameworks in SAP and IT infrastructure management. - Strong understanding of cybersecurity principles in plant IT environments. Your role will require a strategic mindset focused on operational efficiency and business alignment, along with the ability to lead a multidisciplinary team effectively and ensure compliance with regulatory and InfoSec standards.,