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Manager/Sr. Manager/Dy Manager Quality – API | Akums Drugs & Pharmaceuticals | Derabassi

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Akums Drugs & Pharmaceuticals Ltd. is the largest contract manufacturing company engaged in the manufacturing of pharmaceutical formulation, ayurvedic/herbal preparations, hormones, nutraceuticals, and more. Quality, innovations & customer satisfaction are virtues at Akums. The approach is technologically driven to serve the emerging needs in the ever-expanding market. The 9 states of art facilities are dedicated to separate dosage forms across therapeutic segments. The infrastructure is equipped with sophisticated and ultra-modern equipment & machines, with huge manufacturing capacities in all sections. In our continuous pursuit of Healthier today and tomorrow, we are working towards redesigning global healthcare

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When we work at Akums we work in a family. We are committed to providing a warm, friendly, and open working environment that encourages ideas and innovation. The focus is to allow everyone at Akums to enhance their creativity and think differently to create value. We have a deep belief in transparency and perennial growth for each one.

Nurturing an employee-centric work philosophy, we believe  in unleashing the hidden potential of every dedicated member and on  bringing out the best in each one by facilitating holistic growth.

Position: Manager/Sr. Manager/Dy Manager Quality – API

Location: Derabassi, Punjab, India

Job Description:

QUALITY MANAGEMENT SYSTEM:

  • Implementation of Quality Management System at the site.
  • Ensure compliance to Current Good Manufacturing Practices (CGMP).
  • Overall responsible for compliance to in-house and contract projects with respect to Manufacturing.
  • Responsible for closing the OOS reports by providing proper technical justification including a suitable CAPA.
  • Responsible for performing product reviews.

Training:

  • Ensuring training to all employees as per the schedule and imparting training to shop floor personnel as well.
  • Reviewing the training records and assessment sheets

INTERNAL AUDITS:

  • Ensure that the internal audits (self-inspections) are performed as per the schedule.
  • Responsible to make sure that all the critical deviations are investigated and resolved.

SOPs and APPROVALS:

  • Responsible for approving all departmental SOP s.
  • Responsible for reviewing specifications of raw materials, in-process, intermediate, and finished drug substances, packing materials, labeling materials, and standard test procedures.
  • Responsible for approving process validation, cleaning validation, purified water system validation, HVAC, Hold time stability protocols, and reports.
  • Review and approve qualification protocols of instrument/equipment, Analytical method transfer protocols, and reports.

MANUFACTURING SUPPORT:

  • Responsible for reviewing and approval of scale-up, technology transfer and development reports.
  • Responsible for maintaining online documentation
  • Responsible for reviewing, identifying the gaps and support to complete the executed batch records
  • Responsible for reviewing completed batch production and laboratory control records of critical process steps before releasing of the API for distribution.
  • Responsible for releasing or rejecting all API s and Intermediates.
  • Responsible for approving intermediate and API contract manufacturers.
  • Responsible for approving changes that potentially impact intermediate or API quality.

OTHERS:

  • Responsible for acting as Quality Management Representative in the site.
  • Responsible for delegating works to In-Charge-QA in his absence.
  • REGULATORY/CUSTOMER AUDITS:
  • Responsible for all regulatory audits such as USFDA, EDQM, MHRA, KFDA, ANVISA, PMDA, and TGA as a prime auditee.
  • Responsible for customer audits and ensuring to get minimum observations, specifically without any major/critical observations that may lead to data integrity.
  • Should able to handle the audits independently and is accountable to respond on all regulatory queries.

Qualification: B.Tech/B.E. – Bio-Chemistry/Bio-Technology, Chemical, B.Sc – Chemistry, MS/M.Sc(Science) – Chemistry

Experience: 10-15 Years

Salary: Negotiable

Contact Details:

career.progress@akums.net, hrd@akums.net, 

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