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Full-time
bachelor degree
Posted 15h ago
Apply by Jul 31
~40 hrs/week
Responsibilities
Monitor and execute production activities in a pharmaceutical manufacturing area to achieve targets while maintaining cGMP and safety norms. Manage resources, maintain standard process parameters, and ensure accurate online documentation and regulatory compliance.
Requirements
Requires a Bachelor in Pharmacy with 3-4 years of total experience, including at least 2 years in pharmaceutical manufacturing. Must possess knowledge of cGMP practices and formulation production equipment operations.
Full job description
Division
Department
Sub Department 1
Job Purpose
Monitor and execute the production activities in an area during the shift by maintaining cGMP and safety norms to achieve production targets
Key Accountabilities (1/6)
Execute production activities in a shift by managing available resources to achieve production target
Execute assigned tasks as per planned production activity to meet production targets for a shift
Regulate usage of consumables in the production process at optimum levels to save costs
Increase the efficiency of area by utilization of equipment and by reducing downtime in manufacturing area
Key Accountabilities (2/6)
Maintain standard process parameters as per BMRs and other supporting documents for achieving production target and maintaining quality
Ensure all operations are performed as per GMP & Safety norms by reviewing all processes and documents for compliance
Ensure equipment, facility and block premises are maintained as per regulatory compliance
Maintain system integrity by updating documentations and deviations on CipDox while performing operations
Perform validation, qualification and calibration as per schedule and update output of all activities in the systems
Prepare new documents and update existing documents as per GMP requirement
Key Accountabilities (3/6)
Prepare manufacturing records and update online documentation to meet production and cGMP requirements
Maintain online documentation and timely entries in BMR and supporting documents
Prepare new documents and update existing documents as per GMP requirement
Operate software such as SAP, CipDox and QMS
Key Accountabilities (4/6)
Follow safe work processes and ensure safety appliances are utilised during production activities in shifts to create a safe working environment
Ensure safety systems and procedures followed by the operators in the shift
Ensure availability and usage of PPEs in the shift by coordinating with HSE department for requirements and shift schedule
Key Accountabilities (5/6)
Execute production activities in a shift by managing available resources to achieve production target
Execute assigned tasks as per planned production activity to meet production targets for a shift
Regulate usage of consumables in the production process at optimum levels to save costs
Increase the efficiency of area by utilization of equipment and by reducing downtime in manufacturing area
Key Accountabilities (6/6)
Major Challenges
Meeting shift targets due to unavailability of adequate resources. Overcome by efficient work load distribution and resource optimisation
Meeting production targets due to lapses in knowledge transfer between shifts. Overcome by bridging gaps between inter-shift communication
Maintaining cGMP requirements during system downtime. Overcome by coordinating with the engineering team and technical support team
Key Interactions (1/2)
QA/QC for scheduling of batches, issues in product (Daily)
Engineering & Utility for system related queries (Daily)
Formulation Technical Support for troubleshooting in products (Case Basis)
Formulation Technology Transfer for support in new products (Project Basis)
Stores and Warehouse for RM/PM related activities (Daily)
Safety for safety rounds and PPE requirement (Daily)
Key Interactions (2/2)
Maintenance Contractor and vendors for any machine repairs and spares (Case Basis)
Equipment manufacturer: For troubleshooting in machine (Case Basis)
Dimensions (1/2)
Direct Reports : 12 (dotted reporting in shift)
Number of areas managed : 3
Number of dosage forms : 2
Number of tech transfer supported per month : 2
Number of batches executed per month : 35-40
Achieve internal OTIF more than 90%
YOY improvement in shift operations efficiency
Achieve Zero reportable accidents / incidences during manufacturing
Achieve set target for batch failure reduction
Achieve 0% errors in online documentation
Meet 100% compliance to SOP and safety regulations
Dimensions (2/2)
Key Decisions (1/2)
Resource allocation for each shift
Workload distribution in each shift
Key Decisions (2/2)
Up-gradation in Facility and Documents (To Section Head)
Modification in plant and equipment (To Section Head)
Deviation and implementation of CAPAs (To Section Head)
Education Qualification
Bachelor in Pharmacy
Relevant Work Experience
3-4 years of experience with 2 years of experience in pharmaceutical manufacturing
Knowledge of cGMP practices, equipment operations required for Formulation Production