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 Â in unleashing the hidden potential of every dedicated member and on Â bringing out the best in each one by facilitating holistic growth.
Position: Manager/Sr. Manager/Dy Manager Quality – API
Location: Derabassi, Punjab, India
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.
- 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
- 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.
- 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.
- 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
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