Assistant manager / Sr. Executive - Production Sterile

ARKRAY; Surat; On-site; INR 600,000 - 800,000; Full time

Job summary

A pharmaceutical company in Surat seeks an experienced professional with a background in Pharmacy and at least 5 years in production, particularly within aseptic operations. The role focuses on controlling production activities and ensuring compliance with defined procedures and standards. Candidates with familiarity with regulatory audits will have a distinct advantage. This position offers a chance to contribute to high-quality manufacturing operations.

Qualifications

• Min 5 years of experience in Production department in Aseptic operations.
• Hands-on experience with regulatory audits like US FDA or UK MHRA is a plus.

Responsibilities

• Control the production activities and ensure schedule adherence.
• Maintain high standards of cleanliness in low bio burden areas.
• Monitor and control yield losses during production.
• Coordinate with QA and QC for validations and approvals.

Skills

Production department experience

Understanding of Aseptic operations

Knowledge of equipment for sterilization

Knowledge of Process Validation

Regulatory audit experience

Education

Higher Educational background in Pharmacy

Tools

Steam Sterilizer

Lyophilizer

HVAC

Quality Assurance/Quality Control knowledge

Job description

Job Description

Educational background in Pharmacy. Min 5 years of experience in Production department.

Requirements

• Higher Educational background in Pharmacy
• Min 5 years of experience in Production department in Aseptic operations
• Understanding of equipment like Steam Sterilizer, Dry heat sterilizer, Washing Machine, Filling Machine, Lyophilizer, HVAC, water system, compressed air, Nitrogen system etc.
• Understanding on Process Validation for Sterilization, Washing, Aseptic filling, and cleaning procedures.
• Knowledge for evaluation of change control, deviation, and incident, out of specification, out of trend and risk management.
• Prepare the production process SOPs & batch records
• Knowledge for goods manufacturing practices and capacity to provide the training to all concerns.
• Knowledge on Aseptic processes, Lean, OEE and similar KPIs.

Hands-on experience for any of regulatory audits such as US FDA, UK MHRA, ANVISA Brazil, TGA - Australia or MCC South Africa plant experience will be having an added advantage.

Duties and Responsibilities

• To control the production activities
• To ensure schedules are adhered to commitments
• To ensure high standard of housekeeping and cleanliness in low bio burden area.
• To ensure that production is done as per defined procedure & specifications
• To monitor and control the yield losses during the production process.
• Initiate plans and processes which minimize manufacturing costs
• On line completion and reviewing of the batch records and documents.
• Preparation & review of SOPs of the production sterile operations
• Imparting on the Job training to executive and technician about the sterile operations.
• Coordinating with QA and QC for validation and in-process checks and approvals.

Office Location

Surat