12 Nov
|
Medipol Pharmaceuticals India
|
Solan
12 Nov
Medipol Pharmaceuticals India
Solan
Job Description – Production Executive (Pharmaceutical Formulations)
Location: Baddi, Himachal Pradesh (On-site)
Department: Production
Experience: 3–6 Years
Employment Type: Full-time, Permanent
Industry: Pharmaceutical Formulations
Position Overview
We are looking for a technically competent and result-oriented Production Executive to manage and execute day-to-day manufacturing activities in our pharmaceutical formulation facility. The position involves handling shop-floor operations, ensuring compliance with applicable Schedule M and cGMP requirements, maintaining batch manufacturing documentation, and achieving production targets in accordance with approved manufacturing procedures.
The candidate should possess practical experience in pharmaceutical formulation manufacturing, a sound understanding of GMP documentation, and hands-on exposure to production equipment and processes. The role requires close coordination with QA, QC, Engineering, Warehouse, and other cross-functional departments to ensure smooth and compliant manufacturing operations.
Key Responsibilities
1. Manufacturing Operations
- Execute manufacturing activities as per the approved production plan and ensure timely completion of assigned batches.
- Handle and monitor pharmaceutical manufacturing processes such as dispensing, sifting, granulation, blending, compression, coating, capsule filling, and other formulation-related operations, as applicable.
- Ensure manufacturing activities are carried out strictly as per approved Batch Manufacturing Records (BMR) and Standard Operating Procedures (SOPs).
- Monitor critical process parameters at different stages of manufacturing and ensure adherence to approved specifications.
- Ensure proper line clearance, equipment status verification, and area readiness before commencement of manufacturing activities.
- Monitor batch yield, process loss, machine utilization, and production output.
- Report equipment breakdowns, process abnormalities, and production-related issues to the reporting manager.
2. GMP Compliance & Documentation
- Ensure strict adherence to Schedule M, cGMP, approved SOPs, and applicable regulatory requirements.
- Maintain accurate and timely entries in Batch Manufacturing Records (BMR), Batch Packaging Records (BPR), equipment usage logs, cleaning records, and other relevant documents.
- Ensure compliance with Good Documentation Practices (GDP) and ALCOA+ principles of data integrity.
- Ensure proper identification, status labelling, and traceability of raw materials, intermediates, and finished products.
- Follow procedures related to equipment cleaning, area cleaning, product changeover, and prevention of cross-contamination.
- Identify and report deviations, incidents, and non-conformances to the reporting manager and QA department.
- Support QA during internal audits, regulatory inspections, and GMP compliance activities.
3. Equipment & Process Management
- Ensure proper operation and cleaning of pharmaceutical manufacturing equipment.
- Monitor equipment performance and coordinate with the Engineering department for preventive maintenance and breakdown-related activities.
- Ensure equipment cleaning and usage status are properly documented.
- Follow approved procedures for equipment operation, cleaning validation requirements, and manufacturing area clearance.
- Ensure proper handling and utilization of manufacturing equipment to minimize downtime and process losses.
4. Production Coordination
- Coordinate with Warehouse for the timely availability and dispensing of approved raw materials and packaging materials.
- Coordinate with QA for line clearance, in-process checks, and other required quality approvals.
- Coordinate with QC for sampling and testing requirements at different stages of manufacturing.
- Ensure proper coordination with Engineering and Maintenance for equipment availability.
- Monitor daily production progress and submit shift-wise and daily production reports to the reporting manager.
5. Safety, Hygiene & Housekeeping
- Ensure adherence to personnel hygiene, gowning procedures, and entry/exit requirements in manufacturing areas.
- Maintain proper cleanliness and housekeeping in the production area as per GMP requirements.
- Ensure compliance with EHS guidelines and safe operating practices.
- Follow procedures for handling materials, equipment, and manufacturing waste.
- Ensure prevention of mix-ups, contamination, and cross-contamination during manufacturing operations.
Required Qualifications & Experience
- Education: B.Pharm / M.Pharm / M.Sc. in a relevant discipline.
- Experience: 3–6 years of hands-on experience in pharmaceutical formulation manufacturing.
- Technical Expertise: Practical knowledge of pharmaceutical manufacturing processes, including granulation, compression, coating, capsule filling, or liquid manufacturing, depending on the assigned dosage form.
- Regulatory Knowledge: Good understanding of Schedule M, cGMP, WHO-GMP requirements, SOPs, GDP, and ALCOA+ principles.
- Documentation Skills: Hands-on experience in maintaining BMR, BPR, equipment logs, cleaning records, and other production-related documentation.
- Equipment Knowledge: Familiarity with pharmaceutical manufacturing equipment, cleaning procedures, line clearance, and equipment status labelling.
- Functional Skills: Good coordination, problem-solving, communication, and shop-floor management skills.
Pay: ₹300,000.00 - ₹600,000.00 per year
Benefits:
- Cell phone reimbursement
- Flexible schedule
- Food provided
- Leave encashment
- Provident Fund
Application Question(s):
- Do you have B.Pharm/M.Pharm/M.Sc. qualification?
- Do you have 3–6 years of pharma formulation experience?
- Do you have hands-on production experience?
- Have you handled granulation, compression, blending, or coating?
- Do you have practical BMR/BPR documentation experience?
- Are you familiar with Schedule M and cGMP?
- Are you willing to work in office in Baddi?
- Are you comfortable working in rotational shifts?
Work Location: In person
📌 Production Executive (Solan)
🏢 Medipol Pharmaceuticals India
📍 Solan