Job Description
Position: Manager – Production Block Incharge (API Manufacturing)
Location: Maharashtra
Department: Production
Reports To: Head – Manufacturing / Plant Head
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
- Strong 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.
Job DescriptionPosition: Manager – Production Block Incharge (API Manufacturing)Location: MaharashtraDepartment: ProductionReports To: Head – Manufacturing / Plant HeadRole ObjectiveTo lead and oversee the operations of the API production block ensuring compliance with cGMP regulatory standards and ...
Job Description
Position: Manager – Production Block Incharge (API Manufacturing)
Location: Maharashtra
Department: Production
Reports To: Head – Manufacturing / Plant Head
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
- Strong 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.
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