Quality Control-Head

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Quality Control-Head

work outline icon14 - 24 Years of Experiencerupess outline iconNot disclosed time outline iconFull Time

Sovereign Pharma Pvt. Ltd.

time outline iconDiu, Daman and Diu, India

Posted on 04-01-2023

570 Views

1 Vacancy

Description

  • To plan, coordinate & ensure that all quality control activities are being performed as per laid down procedure. This also includes reports received from external laboratory.
  • To ensure the adequate number of qualified personal in the department. To plan, promote and organize training activities related to product quality and reliability. Apart from that ensure the required initial and continuing training of department personnel is carried out and adapted according to need.
  • To overview / Participate during investigation of the deviation, market complaint, breakdown incidences as per OOS, OOT and laboratory incident and timely closure in system with CAPA.
  • To improve pr reject, starting materials, packaging materials, in process samples, intermediate sample, water samples and finished products.
  • To ensure that the appropriate analytical transfer, verification, or validation must be done.
  • To co-ordinate with various parties for CAPEX and revenue items and provide recommendation.
  • To approve the standard operating procedures, specifications, sampling instructions, test methods and other quality documents of quality control.
  • To monitor and maintain the maintenance of department, premises, and equipment of quality control.
  • To approve reports/protocols/validation qualification data related to microbiology sections.
  • To Co-ordinate with other department for better service providing to the internal customer.
  • To review and approve validation/ stability protocols / reports.
  • To ensure compliance with cGMP and GLP requirements.
  • To approve documents related to departmental activities.
  • To ensure an effective quality management system is in place to achieve the quality objectives and that roles, responsibilities, and authorities re defined, communicated, and implemented through the organization. To facilitate, mentor and monitor the desired Quality Culture of the quality team members.
  • To approve calibration of laboratory instruments, preparation of reagents and preparation of volumetric solutions.
  • To prepare and represent the department for External & Internal audit (Customer & Regulatory).
  • To evaluate outside contract analytical laboratories.
  • To ensure 100% Department training attendance of EHS & work permit adherence in department.
  • To maintain safety in department & reporting of plant Near miss / unsafe Act /unsafe Condition / accident /incident.

Category

Pharmaceuticals

Functional Area

Pharma Quality Control (QC)

Preferred Education

MSc (Master of Science)MPharm (Master Of Pharmacy)BSc (Bachelor of Science)BPharm (Bachelor Of Pharmacy)

Key Skills

Quality ControlInjectablesChemicalInternal AuditMicrobiologySterile

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