Production Manager For Romania (Solid oral )

Job Title: Manufacturing Manager Solid Oral Dosage (Tablets, Capsules, Oral Liquids)

Location: Romania (On-site – Full-time)
Department: Production / Manufacturing
Reports To: Plant Head / Operations Director

Job Summary

We are seeking an experienced Manufacturing Manager to lead production operations at our pharmaceutical manufacturing facility in Romania. The role is ideal for candidates willing to relocate from India and work on-site in a regulated EU-GMP environment. The candidate will be responsible for end-to-end manufacturing and packaging operations for solid oral dosage forms and oral liquids, ensuring compliance with EU regulatory standards.

Key Responsibilities

1. Manufacturing Operations

• Manage production activities for tablets, capsules, and oral liquids.
• Oversee granulation, compression, coating, encapsulation, and liquid manufacturing processes.
• Ensure adherence to production schedules and optimize productivity.
• Review and approve Batch Manufacturing Records (BMR).

2. Packaging Operations

• Supervise primary and secondary packaging (blister, bottle, strip, liquid filling).
• Ensure packaging meets EU regulatory and artwork compliance.
• Improve packaging line efficiency and reduce downtime.

3. EU-GMP Compliance

• Ensure compliance with EU-GMP, MHRA, and other regulatory standards.
• Handle regulatory inspections and audits.
• Maintain data integrity and documentation standards.

4. People Management

• Lead and manage production and packaging teams.
• Train and develop local workforce.
• Manage shift planning and manpower allocation.
• Drive a performance-oriented culture.

5. Cross-Functional Coordination

• Coordinate with QA, QC, Engineering, Warehouse, and Regulatory teams.
• Support technology transfer from development sites to manufacturing.
• Ensure availability of raw and packaging materials.

6. Process Improvement

• Implement continuous improvement initiatives (Lean / Six Sigma).
• Drive cost optimization and efficiency improvements.
• Lead CAPA implementation for deviations and investigations.

7. Equipment & Validation

• Ensure maintenance and optimal use of equipment.
• Support qualification (IQ/OQ/PQ) and validation activities.
• Coordinate with engineering for preventive maintenance.

8. EHS & Safety

• Ensure compliance with safety and environmental regulations.
• Promote a strong safety culture within the plant.

Qualifications & Experience

• Bachelor’s/Master’s degree in Pharmacy, Science, or Engineering.
• 10–15 years of experience in pharmaceutical manufacturing.
• Minimum 5 years in a managerial role handling solid oral dosage.
• Strong experience in both manufacturing and packaging operations.
• Prior exposure to EU-GMP / MHRA regulated facilities is highly preferred.

Key Skills

• Strong technical knowledge of solid oral and liquid manufacturing.
• Leadership and team management capability in a multicultural environment.
• Regulatory compliance expertise (EU/MHRA).
• Problem-solving and decision-making skills.
• Good communication and adaptability.

Relocation & Employment Details

• Candidate must be willing to relocate from India to Romania.

• Full-time on-site role at manufacturing facility.

• Company will support:

• Work permit and visa processing

• Relocation assistance

• Initial accommodation support (if applicable)

Preferred

• Experience in technology transfer projects.
• Exposure to European audits (MHRA, EU authorities).
• Experience working in international or cross-cultural environments.

Compensation & Benefits

• Competitive salary (as per European standards)
• Relocation benefits
• Health insurance and other statutory benefits as per Romanian labour laws