API production Manager

Job Summary:

We are seeking an experienced and compliance-driven Production Manager to lead our Oral Solid Dosage (OSD) manufacturing facility in Himachal Pradesh. The ideal candidate will have extensive hands-on experience in managing end-to-end production operations (Granulation Compression Coating and Packing) within a WHO GMP-compliant environment.

The candidate must have a strong command of regulatory documentation and Revised Schedule M guidelines ensuring the facility is audit-ready at all times.

Key Responsibilities:

1. Production Planning & Operations:

• Oversee daily manufacturing operations for Tablets and Capsules ensuring production targets are met efficiently and on time.
• Plan and execute production schedules to align with procurement logistics and market demand.
• Manage man machine and material resources effectively to optimize yield and reduce wastage.
• Ensure smooth technical operations of key machinery (RMG FBD Compression machines Auto-coaters etc.) and coordinate with the maintenance team to minimize downtime.

2. Regulatory Compliance & Quality Assurance (Crucial):

• Revised Schedule M Implementation: Lead the implementation and adherence to the Revised Schedule M guidelines within the facility.
• Ensure all manufacturing activities strictly comply with WHO GMP standards and company quality specifications.
• Champion the Audit Readiness of the plant. Lead the team during regulatory inspections and customer audits.
• Documentation: Maintain absolute data integrity in manufacturing documents. Review and approve Batch Manufacturing Records (BMR) Batch Packaging Records (BPR) and Standard Operating Procedures (SOPs).

3. QMS & Continuous Improvement:

• Manage Quality Management Systems (QMS) related to production including handling Change Controls Deviations and CAPA (Corrective and Preventive Actions).
• Identify process gaps and drive continuous improvement initiatives to enhance product quality and operational safety.

4. Team Leadership:

• Train supervise and motivate the production team (Officers Operators and Technical Staff) to ensure a high-performance culture.
• Promote a culture of safety hygiene and discipline on the shop floor.

Candidate Profile & Requirements:

Must-Haves:

• Current Location: Currently employed in HP Punjab or Uttarakhand.
• Facility Experience: Must have significant prior experience working in a WHO GMP approved facility.
• Regulatory Knowledge: In-depth knowledge of Revised Schedule M guidelines is a non-negotiable requirement.
• Core Competencies: Strong grip on OSD manufacturing processes (Granulation to Packing).

Preferred Qualifications:

• Audit Exposure: Proven track record of facing and successfully managing regulatory audits (e.g. WHO or Semi-Regulated markets). Candidates with experience facing audits are highly desirable.
• Documentation Skills: Candidates with specific strength in handling Change Controls and QMS documentation will be given preference.

Note to Recruiter:

• Strict Filter: Please do not forward profiles from Gujarat or Southern India. Focus exclusively on the Baddi / Mohali / Paonta Sahib / Roorkee / Dehradun pharma belts.
• Screening Question: Ask candidates to cite specific examples of how they have adapted processes to meet Revised Schedule M norms.