Executive Production

APOTEX; Bengaluru; On-site; INR 900,000 - 1,200,000; Full time

Job summary

Apotex is a leading global health company. We are seeking a qualified professional to drive production processes, support QMS activities, and uphold quality across the manufacturing department in Bengaluru.

The role emphasizes SME investigations, process improvement, and regulatory compliance. Applicants should have a Bachelor's degree, substantial experience with cGMP, and a track record in manufacturing quality, investigations, and CAPA.

Qualifications

• Bachelor's degree required.
• Adequate knowledge and ability in Supporting Mfg. SME.
• SME investigation experience.
• In-depth knowledge of cGMP practices.
• Proactive identification and addressing of potential compliance issues.
• Ability to drive continuous improvement initiatives and lead teams.
• Excellent communication and collaboration skills.

Responsibilities

• Drive production processes with focus on QPI, QMS support, on-time production and quality compliance.
• Monitor OEE, yield and product changes for XL-400 & XL-800 machines as part of operation excellence.
• Support manufacturing SME investigations and reporting.
• Collect documents and prepare draft reports for QMS activities.
• Lead root-cause analysis and CAPA with SMEs and ensure regulatory compliance.
• Promote quality and safety practices across the department.
• Prepare reports/presentations for management and stakeholders.
• Ensure adherence to corporate values and HR, safety, and ethics policies.

Job description

Apotex is a Canadian-based global health company. We improve everyday access to affordable, innovative medicines and health products for millions of people worldwide, with a broad portfolio of generic, biosimilar, innovative branded pharmaceuticals and consumer health products. Headquartered in Toronto, with regional offices globally, including in the United States, Mexico and India, we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions.

A role-holder to drive the production process such as strategic QPI, support QMS activities -Collecting documents, supporting operation excellence programme to target on-time production, delivery of product with quality compliance and cost improvisation.

Job Responsibilities

• To be Self-Disciplined & to maintain the same in the department.
• To be always ready to accept new challenges & multifunctional activities.
• Perform investigation without any influence or bias.
• Perform all the necessary task to complete the investigation on time.
• Monitoring OEE, Yield and Product change overs for XL-400 & XL-800 compression machines as a part of operation excellence programme
• To support lead investigator for manufacturing SME related to production department.
• Supporting QMS activities such as collecting documents and preparing draft reports
• Conduct meeting/s with different SME to support deriving the root cause and CAPA for the investigation.
• Ensure all the procedures are followed to complete the investigation.
• Always ensure that GxP practices are followed through the investigation.
• Act as a Quality circle team member representing manufacturing to promote quality across the department.
• Take necessary actions to elevate any serious issue to the manager.
• Whenever required make relevant reports and presentations to support the department.
• Perform all work in support of our Corporate Values of Courage, Passion, Collaboration and Perseverance; Demonstrates strong and visible support of our values.
• Performs all work in accordance with all established regulatory and compliance and safety requirements.
• Works in a safe manner collaborating as a team member to achieve all outcomes.
• Demonstrate behaviour that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion.
• Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies.
• All other relevant duties as assigned.

Job Requirements

• Education
  • Bachelor’s degree
• Knowledge, Skills, and Abilities
  • Adequate knowledge and ability in Supporting Mfg. SME
  • SME investigation.
  • In depth knowledge of cGMP practices
  • Proactively identify and address potential compliance issues.
  • Driving continuous improvement initiatives to optimize processes.
  • Demonstrating ability to lead teams fostering a culture of quality and accountability.
  • Exceptional communication and collaboration skills enabling effective engagement.
• Experience
  • 6 Years 07 Months

At Apotex, we are committed to fostering a welcoming andaccessible work environment, where all everyone feels valued, respected, and supported to succeed.

We offer accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.