Assistant Production Manager (Noida)

Assistant Production Manager (Noida)

13 Oct
|
Ochron Pharma Private
|
Noida

13 Oct

Ochron Pharma Private

Noida

Company Name: Ochron Pharma Private Limited
Department: Production, Engineering Coordination & Plant Operations
Job Location: Greater Noida, Uttar Pradesh, India
Position Type: Full time
Reporting To: Director / Management

1. Job Purpose

Ochron Pharma Private Limited is seeking an experienced and technically competent Pharma Production Manager to lead the initial setup, machinery procurement, installation, commissioning, and end-to-end operations of a pharmaceutical manufacturing facility.

The ideal candidate must have practical experience in establishing a pharmaceutical manufacturing plant from the ground up, including preparation of equipment requirements, evaluation of machinery manufacturers, technical and commercial negotiations, plant layout planning, utility coordination, equipment qualification, GMP compliance, and the commencement of commercial production.

The candidate will be responsible for overseeing the complete manufacturing operations of solid dosage forms, including tablets and capsules, and semi-solid dosage forms, including creams and ointments, in accordance with applicable GMP requirements and regulatory standards.

2. Key Roles and ResponsibilitiesA. Pharmaceutical Plant Setup & Project Execution

- Lead the complete pharmaceutical manufacturing plant setup from the initial planning stage to commercial production.
- Prepare a detailed machinery and equipment requirement list based on the proposed manufacturing capacities and dosage forms.
- Develop and review the production area layout, equipment placement, material flow, personnel flow, and process flow.
- Coordinate with management, consultants, architects, HVAC contractors, utility suppliers, and equipment manufacturers.
- Prepare and monitor project timelines for machinery procurement, installation, commissioning, and production readiness.
- Identify technical requirements for manufacturing areas, dispensing rooms, granulation rooms, compression rooms, coating areas, capsule manufacturing, and semi-solid production areas.
- Ensure that production infrastructure is designed to support GMP-compliant operations.

B. Machinery Procurement & Technical Evaluation

- Possess comprehensive knowledge of pharmaceutical manufacturing machinery, its working principles, technical specifications, production capacities, and applications.
- Prepare User Requirement Specifications (URS) for all production equipment in accordance with applicable GMP requirements.
- Identify suitable Indian and international machinery manufacturers and suppliers.
- Obtain and compare at least 3–5 quotations for major equipment wherever practical.
- Evaluate quotations based on technical specifications, quality, capacity, construction material, automation, GMP suitability, after-sales service, warranty, delivery timelines, and total cost of ownership.
- Conduct technical and commercial negotiations with machinery manufacturers to obtain competitive prices and favorable payment terms.
- Verify whether proposed equipment is suitable for the intended products, batch sizes, production targets, and future expansion.
- Coordinate factory visits, equipment demonstrations, technical discussions, and supplier assessments.
- Review equipment drawings, General Arrangement (GA) drawings, technical datasheets, electrical requirements, and utility consumption.
- Support preparation of purchase orders, delivery schedules, inspection plans, and equipment acceptance criteria.
- Coordinate with suppliers for documentation, spare parts, manuals, training, installation, and commissioning.

C. Machinery Installation, Commissioning & Qualification

- Supervise installation and commissioning of all production machinery.
- Coordinate installation requirements for electrical systems, compressed air, water systems, HVAC, steam, vacuum, and other applicable utilities.
- Verify that equipment installation complies with approved specifications and applicable GMP requirements.
- Coordinate Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), as applicable.
- Ensure that equipment calibration, maintenance plans, operating manuals, and preventive maintenance schedules are established.
- Coordinate with Quality Assurance (QA), Quality Control (QC), Engineering, and external qualification agencies.




- Ensure that machinery is released for routine production only after the required approvals and qualification activities are completed.

D. Production Machinery Knowledge

Solid Dosage Manufacturing – Tablets and Capsules

The candidate should have practical knowledge of the following equipment and processes:

- Raw material dispensing and weighing systems.
- Sifting machines and vibro sifters.
- Rapid mixer granulators / high-shear granulators.
- Fluid bed dryers (FBD).
- Multimills, cone mills, and oscillating granulators.
- Blenders, bin blenders, and octagonal blenders.
- Tablet compression machines.
- Tablet coating machines and perforated coating pans.
- Automatic capsule filling machines.
- Capsule polishing and inspection equipment.
- Tablet dedusters and metal detectors.
- Blister and strip packing machines.
- Cartoning machines, batch coding systems, and secondary packaging equipment.

Semi-Solid Manufacturing – Creams and Ointments

The candidate should understand:

- Manufacturing vessels and vacuum emulsifying mixers.
- Homogenizers and high-speed mixing systems.
- Heated and cooled manufacturing vessels.
- Stainless steel storage vessels and transfer pumps.
- Tube filling and sealing machines.
- Batch coding, labeling, and packaging equipment.

The candidate must be able to assess equipment suitability, production capacity, process requirements, cleaning requirements, and equipment integration.

E. Production Planning & Execution

- Develop production plans based on approved orders, demand forecasts, inventory, and available capacity.
- Prepare batch-wise manufacturing schedules and manpower plans.
- Supervise dispensing, manufacturing, compression, coating, capsule filling, and packaging activities, as applicable.
- Ensure adherence to approved Batch Manufacturing Records (BMRs) and Batch Packaging Records (BPRs).
- Monitor production output, yield, rejection rates, downtime, and equipment utilization.
- Identify bottlenecks and implement corrective measures to improve productivity.
- Ensure proper coordination between Production, QA, QC, Stores, Engineering, and Supply Chain.
- Maintain production discipline and ensure timely completion of manufacturing and packaging activities.

F. GMP, WHO-GMP & Regulatory Compliance

- Ensure that production activities comply with applicable Schedule M, GMP, and relevant WHO-GMP requirements, as applicable to the facility and intended markets.
- Implement SOPs, line clearance procedures, in-process controls, equipment cleaning procedures, and documentation practices.
- Ensure proper material, personnel, and product movement to minimize mix-ups and cross-contamination.
- Coordinate with QA and QC for sampling, testing, batch documentation review, deviations, CAPA, and change control.
- Support process validation, cleaning validation, equipment qualification, and other required validation activities.
- Maintain data integrity, traceability, and complete production documentation.
- Support regulatory inspections, internal audits, customer audits, and corrective action implementation.
- Ensure that no batch is released without the required quality review and authorized release.

G. Vendor Management & Cost Control

- Develop a qualified network of machinery manufacturers, engineering contractors, and technical service providers.
- Negotiate equipment prices, installation charges, warranty terms, service agreements, and spare parts availability.
- Track machinery procurement budgets and identify opportunities for cost optimization without compromising quality.
- Monitor supplier performance, delivery commitments, and technical compliance.
- Maintain machinery comparison sheets, technical evaluation reports, and procurement documentation.
- Recommend cost-effective equipment that meets production, safety, quality, and regulatory requirements.

H. Team Management & Department Coordination

- Recruit, train, and supervise production officers, supervisors, operators, and supporting personnel.
- Develop departmental responsibilities, reporting structures, and performance indicators.




- Coordinate with Engineering, QA, QC, Regulatory Affairs, Warehouse, Purchase, and Accounts.
- Establish shift schedules, manpower utilization plans, and training programs.
- Promote a culture of accountability, safety, discipline, and continuous improvement.

I. Plant Operations & Performance Monitoring

- Take responsibility for the smooth functioning of production operations after plant commissioning.
- Establish key performance indicators for production output, yield, downtime, rejection rates, and equipment efficiency.
- Ensure availability of raw materials, packaging materials, utilities, manpower, and production documentation.
- Monitor maintenance activities and coordinate timely resolution of equipment breakdowns.
- Prepare daily, weekly, and monthly production reports for management.
- Identify operational risks and recommend corrective and preventive actions.
- Support capacity expansion, new product introduction, and continuous improvement initiatives.

3. Educational Qualifications

- B.Pharm or M.Pharm preferred.
- B.Sc. / M.Sc. in Chemistry or a related discipline may be considered where supported by relevant pharmaceutical manufacturing experience.
- Additional training in pharmaceutical GMP, validation, production planning, and project management will be an advantage.

4. Experience Required

- Approximately 8–12 years of relevant experience in pharmaceutical manufacturing, with suitable experience in a production leadership role.
- Previous experience in pharmaceutical plant setup, greenfield projects, machinery procurement, installation, and commissioning is strongly preferred.
- Practical experience in tablet and capsule manufacturing is essential; exposure to cream and ointment manufacturing is highly desirable.
- Experience in machinery supplier evaluation, technical negotiations, URS preparation, and GMP documentation is required.
- Candidates who have independently handled plant setup from project planning through commercial production will be given preference.

5. Essential Skills

- Strong technical understanding of pharmaceutical production machinery.
- Ability to independently prepare equipment specifications and evaluate technical quotations.
- Excellent negotiation, vendor management, and project coordination skills.
- Knowledge of GMP, WHO-GMP, Schedule M, qualification, validation, and pharmaceutical documentation.
- Strong leadership, analytical, planning, and problem-solving abilities.
- Ability to manage multiple activities and deliver projects within agreed timelines and budgets.
- Proficiency in MS Excel, Word, production reporting, and project tracking.

6. Key Performance Indicators (KPIs)

The candidate's performance will be evaluated on:

- Timely completion of machinery procurement and plant setup milestones.
- Compliance of procured equipment with approved technical specifications and applicable GMP requirements.
- Achievement of installation, commissioning, and qualification targets.
- Adherence to approved project budgets and procurement timelines.
- Readiness of production areas, equipment, documentation, and trained manpower.
- Achievement of production targets, yield, and equipment utilization.
- Reduction in breakdowns, production losses, and avoidable rejections.
- Maintenance of GMP compliance and timely closure of audit observations.
- Effective coordination across departments and suppliers.
- Successful transition from plant setup to routine commercial manufacturing.

7. Overall Responsibility

The selected candidate will be expected to act as a key technical and operational leader for Ochron Pharma Private Limited, taking ownership of the pharmaceutical manufacturing project from the initial machinery selection and procurement stage through plant installation, commissioning, GMP readiness, and ongoing production operations.

The candidate must be capable of working independently, advising management on technical and commercial decisions, controlling project costs, coordinating all relevant departments, and establishing an efficient, compliant, and scalable pharmaceutical manufacturing operation.

Note: Final responsibilities and authority will be defined by management in accordance with the company's organizational structure and applicable regulatory requirements.

Pay: ₹25,000.00 - ₹30,000.00 per month

Benefits:

- Cell phone reimbursement
- Food provided
- Paid sick time

Work Location: In person

📌 Assistant Production Manager (Noida)
🏢 Ochron Pharma Private
📍 Noida

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