Exposure to Regulatory Audits will be preferred 1. Responsible for Overall Quality Management System. 2. Responsible for Approval of general documents (but not limited to) Site Master File, Validation Master Plan, Validation/Qualification Protocols/ Report & yearly calibration Calendars. PM Planners, BMR/ BPR, SOPs, APQR, IPQR, Specifications, Standard testing procedures, general testing procedures etc. 3. Responsible for review and approval of market complaint, change control through EQMS, OOS, OOT, product recall, mock recall and coordination of same with third party/ regularly for intimation/ notification/approval. 4. To form investigation team and monitor effective implementation of CAPA associated with incidents, OOS, complaints, deviation, OOT recalls or any other quality element. 5. Responsible for compliance with technical or regulatory requirements related to the quality of finished products and the approval of the release of finished product distribution and sale. 6. Responsible for inspection, investigation and taking of samples in order to monitor factors that may affect product quality. 7. To ensure compliance of data integrity either manual data or electronic record. 8. Implementing and monitoring all Quality Assurance systems to ensure compliance with CGMP/regulatory guidelines, develop progressive Quality Culture across the organization. 9. Developing and implementing the Quality departments strategy, to ensure it meets the business requirements and customer deliverables, as well as enhancing the departmental performance. 10. Implementing and maintaining a Quality Risk Management system to ensure that risks are adequately controlled and deliver a quality product as per CGMP. 11. Reviewing and approving Technical and Quality Agreements. 12. Work across all disciplines (e.g. manufacturing, packing, warehouse, engineering, QC, QA, RA, HR, R&D) to ensure the all-time readiness of plant for various GMP compliance audits. 13. Ensuring that all activities are performed in accordance with CGMP, company SOPs and Health and Safety policies. 14. Audit, Approval and monitoring of contract manufacturers, Supplier and outside Laboratories as per GMP requirement. 15. Responsible to ensure that process validation, cleaning validation, equipment validation, Preventive maintenance, calibration etc. activities are being carried as per schedule. 16. Responsible to ensure self-inspection/internal audit is being performed as per schedule and its compliance. 17. Ensure that training & development program implemented as per respective SOPs. 18. Responsible for external audit and its compliance. 19. Responsible to ensure to update all legal/ technical changes with respect to new pharmacopoeia/addendum/guidelines. 20. Responsible for ensure stability studies of products are being performed as per schedule. 21. Overall monitoring of new product introduction through technology transfer documents. 22. Responsible to follow EHS Policies. 23. Responsible to ensure implementation of quality policy of the organization.

Role & responsibilities Key deliverables Supervise compliance of cGMP and any other applicable regulatory requirement, including EH&S requirements. Complete self-training and monitor training of team members on the relevant SOPs. Report any quality concern or suggestion for improvement to managers. Execute and supervise all tasks and activities as per the applicable SOPs. To lead and guide site investigation teams to investigate the reported OOS, repeat OOT, deviations and market complaints by working closely with site CFT and operating personnel, to arrive at appropriate RCA and CAPA. To personally lead major/critical/repeat investigations and ensure proper closures. To review and share weekly / monthly report of investigation with focus on key findings, repeats, open issues, CAPA effectiveness, learnings etc. , to the management. To analyze historical data of investigations periodically, to derive trends emerging on any findings or any quality concerns or improvements and notify the management. To review and improve quality of investigations of other investigation members in terms of technical report writing skills as per format. To conduct training programs on technical/ GMP related topics and ensure trainings of subordinates / team members. To participate and support in Investigation management formats, matrices design and implementation. To provide support to site during regulatory inspection or audits / Inspections conducted by local regulatory bodies / vendors / third parties, for related investigation. To support the Quality Management Systems document closure - Deviations, OOS, OOT, LIR and market complaints, change control and CAPA, ensure upkeep of documents related to investigations and ensure compliance in QAMS as per requirement. To perform any additional activity related to investigation as and when required. Key customers Preferred candidate profile Education: B. Pharm / M/Pharm Competencies Education Work Experience 10 to 15 Years Perks and benefits As per standard norms

Responsibilities: Responsible for ensuring CGMP compliance on shop floor. Responsible for line clearance during Dispensing, Manufacturing, and Packing. Responsible for performing in-process checks during different stages as Dispensing, Manufacturing, and Packing. Responsible for AQL inspection. Responsible for Sampling of process validation batches and Cleaning validation as per sampling plans defined in protocol from different stages and different location of process. Responsible for sampling at different stages of manufacturing and packing and submitted the sample to QC/QA. Responsible for Quarantine management. Responsible for daily Balance verification and monthly calibration. Responsible for stage wise release of batches through LIMS and ERP. Responsible for stage wise generation of under test and approved label through ERP and affix the label on product container label. Responsible for request generation and printing of additional pages of BMR /BPR through EDCS. Responsible for pack stock checking and verification at finished product. Responsible for verification of Finished Good Transfer Note. Responsible for on line review of executed log books and BMR /BPR. Responsible for on line review e-log entries on a daily basis. Responsible for Handling of Incident/Deviation change control and CAPA. To ensure that the entry & exit procedures, gowning (Primary & Secondary, color code) procedures, Personnel Hygiene procedures are followed strictly. Show more Show less

Key Responsibilities: 1. Production and Packing Line Planning: • Create and manage detailed production schedules, ensuring machine availability and minimal downtime. • Ensure coordinated loading of production and packing lines to prevent bottlenecks. • Maintain a daily and weekly machine utilization plan aligned with client requirements and delivery timelines. 2. Rolling Forecast Management: • Receive and process rolling forecasts from clients, typically structured as: • Month 1 & Month 2: Firm Purchase Orders (POs). • Month 3: Tentative demand, subject to updates. • Continuously update production schedules each month as forecasts are refined. • Align resources and capacities with forecast changes to avoid production disruptions. 3. Client Coordination: • Communicate with clients to confirm timelines, address changes in forecasts or priorities, and update them on batch statuses. • Share reports on batch progress, planned timelines, and any delays with clients. • Manage last-minute client changes (e.g., batch priority changes) with minimal disruption to operations. 4. Line Balancing: • Assess and implement optimal product flows to avoid machine idling or overload. • Allocate resources (manpower and materials) to match planned machine capacities. • Balance tasks between multiple production and packing lines to minimize cycle time differences. 5. Coordination with Cross-Functional Teams: • Quality Control (QC): Coordinate QC sampling, analysis, and release of materials and batches to avoid delays. • Production and Packing Teams: Align schedules with department heads to ensure resource availability (e.g., operators, shift plans, changeover times). • Quality Assurance (QA): Ensure IPQA approvals and validations are coordinated with the line schedule to avoid interruptions. 6. Machine Changeovers and Preventive Maintenance Coordination: • Schedule production batches in line with planned maintenance activities to avoid clashes. • Minimize changeover times between batches by optimizing machine cleaning and setup times. 7. Capacity Utilization Tracking and Reporting: • Track and report machine utilization and downtime to identify areas for improvement. • Generate reports on daily output vs. planned production and packing to management. • Maintain data on batch adherence to TAT (Turnaround Time) targets. 8. Deviation Management: • Handle deviations in production schedules due to QC delays, machine breakdowns, or manpower shortages by reworking loading plans. • Communicate critical deviations to management and propose mitigation plans. 9. MIS (Management Information System) and Dashboard Reporting: Key MIS Reports to be Generated: • Daily Production Report: Shift-wise machine loading, batch progress, and QC release status. • Rolling Forecast vs. Production Plan: Track alignment of monthly rolling forecasts against actual production. • Weekly Planning Report: Consolidated report showing machine utilization, pending batches, and deviations. • Monthly Summary: Total batches completed, machine uptime, changeover time analysis, and TAT compliance. • Client Dashboard: Customized reports for clients showing batch status, expected release dates, and shipment timelines. • Deviation and RCA Report: Summary of major deviations during the month with RCA (Root Cause Analysis) and CAPA (Corrective and Preventive Actions). Key Dashboard Metrics: • Production Metrics: • Planned vs. Actual Batch Production • Machine Utilization (%) • Changeover Time (minutes per batch) • QC Metrics: • Sampling and Release TAT (Turnaround Time) • Number of Pending QC Approvals • Packing Metrics: • Packing Line Utilization (%) • Planned vs. Actual Output • Deviation Metrics: • Number of Line Downtimes • Number of QC Holds and Reasons • Client Metrics: • Number of Client Deliverables Met On-Time (%) • Pending Client Approvals Dashboard Formats: • Visual representation: Bar charts for machine utilization, pie charts for deviation categories, and timelines for TAT adherence. • Real-time updates: Link data from the ERP/LIMS system to generate automatic daily updates. • Drill-down options: Ability to view department-specific or batch-specific data for detailed analysis. 10. Regulatory Compliance and Documentation: • Ensure production schedules are compliant with regulatory requirements. • Maintain records of planned vs. actual production for regulatory inspections and internal audits. Key Deliverables: 1. Daily Machine Loading Plans: Detailed loading plan for each shift, including batch allocation. 2. Rolling Forecast vs. Production Plan Reports: Comparison of client forecasts vs. actual production. 3. MIS Reports: A comprehensive set of production, QC, and client reports. 4. Dashboards: Visual, real-time summaries of production and packing status. 5. Deviation Analysis: Root cause analysis reports for any deviations from the production plan. Educational Qualifications for Candidate Selection: • Minimum Qualification: Bachelor’s Degree in Pharmacy (B.Pharm), Engineering (Mechanical, Industrial, or Production), or Science (B.Sc.). • Preferred Qualification: Master’s in Pharmacy (M.Pharm), MBA in Operations, or certification in Production Planning (such as APICS, Lean Six Sigma, or SAP ERP certification). • Experience: • Essential: 5+ years of experience in pharmaceutical manufacturing/CMO operations, specifically in OSD production planning. • Desirable: Experience in handling client coordination for rolling forecasts and managing ERP/MIS-based planning systems. Additional Skills Required: • Proficiency in Excel, ERP systems, and scheduling tools (SAP, Oracle, MES, etc.). • Strong analytical and problem-solving abilities. • Excellent communication skills for cross-functional coordination and client management. • Proficiency in dashboard creation tools (Power BI, Tableau) for MIS reporting. • Strong organizational and multitasking abilities to handle rolling changes in forecasts without compromising deadlines. Show more Show less

Roles and Responsibilities Reporting to COO. Responsible for Production, Engineering, warehouse, HR & PPIC department day to day operations & output. All listed dept. head shall be reporting to Plant Head. Ensuring all time audit readiness (ATR) & GMP compliance. Responsible for overall daily & Monthly production plan including but not limited to scheduling, executing, monitoring and controlling. Responsible for cross functional department coordination to align with monthly production goals & annual business plan. / Executing Production/Packaging operations. Responsible for Production, Engineering, warehouse, HR & PPIC department day to day operations & output. All listed dept. head shall be reporting to Plant Head. Responsible to ensure quality, yield, efficiency , productivity & OTIF . Should be team player & willing to lead by example. Key management person to face regulatory and client audit. Should be well versed with process automation and 21 CFR compliances in manufacturing & quality operations. Should have good presentation skills to create , monitor and present MIS monthly, quarterly & project specific. Should be well versed with PV, CV, Equipment qualification, APQR, QMS etc. Should be hands on with ERP/SAP, Quality softwares controlling Documentation, QMS, Training etc. Improve plant operations w.r.t initiatives for process improvement, unit operations, maintenance, hygience, training and safety. Responsible for Customer satisfaction and Reliability. Cross functional working with Quality Head and actively participate in trouble shooting, investigations related to operation incidents , deviations ,market complaint , CAPA , Risk Assessment & Mitigation strategies. Monitoring of Monthly plan with Operating Managers. Allocate resources effectively and fully utilize assets to produce optimal results. Project discussions and coordinating for on time project completion. Focus on Energy Conservation. Coordination for tech transfer activities. Coaching, Motivation, and Morale-Building to reduce attrition. Desired Candidate Profile Perks and Benefits

Job Summary: The Plant Head will be responsible for the overall management and performance of Production, Packing, Engineering, Warehouse, HR, and PPIC departments. This role will oversee day-to-day operations, ensure compliance with regulatory standards, drive operational excellence, and lead cross-functional collaboration to meet organizational goals. Departmental heads will report directly to the Plant Head. Key Responsibilities: Lead and manage daily operations of Production, Engineering, Warehouse, HR, and PPIC departments. Ensure all departments meet performance goals in quality, yield, productivity, efficiency, and OTIF (On Time In Full). Develop, schedule, and monitor daily and monthly production plans aligned with business targets. Maintain audit readiness and full compliance with GMP, 21 CFR, and other regulatory standards. Act as the key point of contact for regulatory and client audits. Lead and support cross-functional coordination to achieve production and business goals. Oversee and execute production and packaging operations, ensuring optimal resource utilization. Monitor plant performance and drive continuous process improvement in operations, hygiene, safety, and training. Actively participate in troubleshooting, deviation management, CAPA, risk assessments, and mitigation strategies with Quality teams. Coordinate and lead technology transfer projects and ensure timely completion of new initiatives. Champion energy conservation and sustainable practices within plant operations. Ensure proper documentation, QMS compliance, and ERP/SAP system usage across departments. Maintain and present MIS reports on monthly, quarterly, and project-specific bases. Ensure equipment qualifications, APQR, PV, CV, and related quality functions are properly managed. Promote a team-oriented culture through coaching, motivation, and morale-building to reduce attrition. Coordinate with Operating Managers for monthly planning and resource allocation. Ensure high standards of customer satisfaction and plant reliability. Show more Show less

Acme Group invites candidates to attend Walk-in interview @ Dehradun on 22nd June' 2025, Sunday from 9:30 AM to 4:00 PM. We are hiring for multiple positions in Production, Packing, Quality Assurance, Quality Control, Microbiology and Engineering. Production (Sterile):- Sr. Executive/ Executive/Sr. Officer/Officer Qualification: B. Pharma/ M. Pharma Experiences: 02 to 08 Years Skills: Good Knowledge of Washing & Tunnel Manufacturing/ Liquid Vial and ampoule filling /Sealing/Autoclave/TS/ /Lyo. /Track & Trace/ Visual Inspection & Packing. Production (Sterile):- Operator/Technician Qualification: ITI/Diploma/D. Pharma Experiences: 04 to 10 Years Skills: Good Knowledge of Washing & Tunnel Manufacturing/ Liquid Vial and ampoule filling /Sealing/Autoclave/TS/ /Lyo. /Track & Trace/ Visual Inspection & Packing Production (Tablet and Capsule):- Operator/Technician Qualification: ITI/Diploma/D. Pharma Experiences: 04 to 10 Years Skills: Granulation Machines (RMG, FBE, FBP), Compression Machines (Fette, Cadmach, CTX), Coating Machines- (Neocota, Sejong, Wurster Coaters, Solid Drug Layering Machines) Capsules & Filling Machines- AF90T, AF150T, etc. Production (Tablet and Capsule):- Sr. Executive/ Executive/Sr. Officer/Officer Qualification: : B. Pharma/ M. Pharma Experiences: 02 to 08 Years Skills: Monitoring and control of shop floor activities and online documentations like Log Book, Batch Records. Exposure to Qualification/ Validation/SOP preparation. Quality Assurance (Sterile and OSD) : Sr. Executive/ Executive/Sr. Officer/Officer Qualification: B. Pharma/ M. Pharma/ M.Sc Experiences: 02 to 08 Years Skills: Good Knowledge of Qual. & Validation/ QMS/Documentation/ Training/ IPQA/AQA/ Audit & Compliance/ Vendor Qualification/ Micro Compliance. Quality Control (Sterile and OSD): Sr. Executive/ Executive/Sr. Officer/Officer Qualification: B. Pharma/ M. Pharma/ M.Sc Experiences: 02 to 08 Years Skills: Experience in sampling and analysis RM, PM,AMV/Stability and FP testing proficiency. Hand on Experience in handling instruments: HPLC, GC, UV, IR, KF. QC Microbiology: Executive/Sr. Officer/Officer Qualification : M.Sc Micro Experiences : 02 to 08 Years Skills :Good Knowledge of EM/GPT/Media Preparation/Water / GLP/ Bioburden /Culture. Engineering: Sr. Executive/ Executive/Sr Officer/Technician Qualification: B. Tech/Diploma Experiences: 02 to 08 Years Skills :Good Knowledge of Injectable Process Equipment (Candidates must have experience with Filling lines such as B+S, Bosch, Groninger, Optima, Tofflon, Steriline, Truking, IMA, Filling Lines, Autoclave, Vessels, and Lyophilizers. etc.)/ Utility/HVAC/ Water System/Chiller/Boiler . Other: Please carry 2 copies of your CV for the Drive In case you are not able to attend, send your CV to career@acmeformulation.com & recruitment@immacule.in Walk-in details and Venue: Date: 22nd June, 2025, Sunday Time: 09:30 am to 04:00 pm Interview Venue: The Competent Palace, Chakrata Road, Selaqui Industrial Area, Central Hope Town, Dehradun, Uttarakhand - 248197. Desired Candidate Profile Perks and Benefits