22 Sep
|
rudransh group
|
Roorkee
22 Sep
rudransh group
Roorkee
ResponsibilitiesThe Production Head must approve and authorize key documents and operational protocols before they advance to QA:Batch Manufacturing Records (BMR) & Batch Packing Records (BPR): Reviews and approves the execution entries to confirm that the batch was processed exactly according to the Master Formula.Master Formula Records (MFR): Jointly signs off on new or updated product formulation designs alongside QA.Standard Operating Procedures (SOPs): Reviews, updates, and approves all internal technical SOPs for equipment operation, cleaning, and material handling.Validation Protocols and Reports: Authorizes plans for process validation, equipment qualifications (IQ/OQ/PQ), and critical cleaning validation studies.Quality Management System (QMS) Documents: Reviews and signs off on shop-floor Deviations, Change Controls, and Corrective and Preventive Actions (CAPA) before final QA sign-off.Dosage-Specific ResponsibilitiesThe physical characteristics of each formulation dictate unique operational risks that the Production Head must monitor and approve:1. Solid Orals (Tablets & Capsules)Granulation & Blending Approval: Reviewing parameters like moisture content (LOD) and blend uniformity before proceeding to compression or filling.Tooling & Machine Parameters: Reviewing and approving tablet tooling drawings (punches/dies)
and setting strict operational limits for compression forces, speed, and weight variation.Yield & In-Process Checks: Approving yields at key steps and investigating any out-of-trend (OOT) physical defects (e.g., tablet capping, capsule splitting).2. Oral Liquids (Syrups & Suspensions)Mixing & Dissolution Verification: Verifying correct temperature profiles, mixing speeds, and filtration systems (to avoid microbial or particulate contamination).Clean-in-Place (CIP) / Sanitize-in-Place (SIP): Approving the specific cleaning parameters and holding times for compounding vessels and transfer pipelines to prevent cross-contamination.3. Semi-Solids (Ointments, Creams & Gels)Homogeneity & Viscosity Controls: Ensuring structural consistency by monitoring and approving heating/cooling cycles, emulsification speeds, and vacuum controls (to prevent aeration).Tube Filling & Sealing Seams: Verifying integrity testing of tube seals (crimp or sonic seals) to guarantee no leakage or product degradation.
Pay: ₹90,000.00 - ₹100,000.00 per month
Advantages:
- Commuter assistance
- Flexible schedule
- Food provided
- Internet reimbursement
- Leave encashment
- Life insurance
- Paid sick time
- Provident Fund
Education:
- Bachelor's (Required)
Experience:
- Production : 10 years (Required)
Work Location: In person
📌 Production head( liquid, tablet, capsules & ointment approval) (Roorkee)
🏢 rudransh group
📍 Roorkee