Role Objective

To lead and oversee the operations of the API production block, ensuring compliance with cGMP, regulatory standards, and safety protocols while driving efficiency, productivity, and quality in manufacturing processes.

Key Responsibilities

Production Management

Plan, organize, and supervise daily operations of the API block.
Ensure adherence to production schedules, yield targets, and cost efficiency.
Monitor batch manufacturing records (BMR) and ensure timely documentation.

Compliance & Quality

Maintain strict compliance with cGMP, FDA, MHRA, and other regulatory requirements.
Coordinate with QA/QC to ensure product quality and resolve deviations.
Drive continuous improvement initiatives to minimize deviations and improve process robustness.

Team Leadership

Lead, train, and motivate production staff to achieve operational excellence.
Ensure manpower planning, shift allocation, and skill development.
Foster a culture of safety, accountability, and teamwork.

Safety & Environment

Ensure compliance with EHS (Environment, Health & Safety) standards.
Conduct regular safety audits and risk assessments.
Implement corrective and preventive actions for unsafe practices.

Process Optimization





Identify bottlenecks and implement process improvements.
Collaborate with engineering and R&D; for technology transfer and scale-up.
Drive lean manufacturing and cost-saving initiatives.

Qualifications & Experience

Bachelor’s/Master’s degree in Chemical Engineering / Pharmacy / related discipline.
15–20 years of experience in API manufacturing, with at least 3–5 years in a supervisory/managerial role.
Strong knowledge of cGMP, regulatory guidelines, and production processes for APIs.
Proven leadership skills with ability to manage cross-functional teams.
Hands-on experience in handling audits (USFDA, EMA, WHO, etc.).

Competencies

Strategic planning and execution
Robust analytical and problem-solving skills
Excellent communication and interpersonal abilities
Attention to detail and documentation accuracy
Ability to work under pressure and meet deadlines

What We Offer

Opportunity to lead a critical production block in a growing pharma organization.
Exposure to global regulatory environments and advanced manufacturing practices.
Competitive compensation and career growth opportunities.

Required Skill Profession

Other General

📌 Manager/Sr. Manager/AGM Production Block Head API (Ankleshwar)
🏢 Talental Consultings
📍 Ankleshwar