quality assurance manager - gmp - vap in ahmedabad

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ahmedabad, gujarat
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Pharma, healthcare & lifesciences
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?Job Description : Quality Assurance Manager (GMP) provides Assurance to the Management that Facilities, Equipment, Personnel, Methods, Records, Controls, Validations, Procedures, Processes and Practices are in conformance with all applicable GMP (Good Manufacturing Practice) Regulations, Standards and/or Specifications

Ensure that there is a system in place for the batch release of API's, starting materials, packaging materials and finished products
Administration of Change Management Program to include document and critical system change control
Ensure the review and approval of executed batch records and oversight on executed laboratory control records, sampling records and associated (executed) records. If errors have occurred, ensure that error have been fully investigated, resolved and properly documented prior to disposition
Maintain an archive of executed batch production records
Responsible for assuring appropriate selection of stability samples
Responsible for managing all external audits of site GMP activities at a pre-approved frequency. Assure audit reports are issued to Site Manager and that suitable and effective actions are taken on a timely basis and followed up on subsequent audits
Monitor Regulatory Compliance rules and regulations, as well as coordinate and advise other departments on all regulatory agency communications relative to compliance issues
Ensure that the batches are produced in compliance with Marketing Authorization and GMP requirements before release of API for distribution
Provide the necessary Quality Assurance support to the GMP Compliance Teams
Ensure that manufacturing and cleaning processes are validated, approve the corresponding protocols and reports
Ensure that the IT systems are qualified and approve the corresponding documents
Ensure that in case of deviations, investigations are made to determine the root cause and corrective actions are defined
Ensure that QA evaluation and approval of OSS (out of specification)/ OTT (out of trend)
Ensure the QA approval for all quality relevant CAPA measures
Approve reworking/ reprocessing requests and protocols
Ensure preparation and approve product quality reviews, annual reviews and documents for ongoing process verification
Ensure evaluation of product technical complaints
Ensure quality oversight of the supply chain products
Support management of quality critical issues and product recalls according to Bayer Regulations
Support evaluation of GMP relevant changes related to products, processes, procedures, equipment and facilities that have the potential to impact upon the quality, safety or effectiveness of products
Approve SOPs related to quality aspects
Ensure there is a system for QA approval of specifications and test procedure form sheets
Ensure the compilation and conduct of Site Quality Management Reviews and subsequent CAPAs
Support all GMP related inspections, by Authorities, Corporate and customers
Review and approve Site Master Files
Review and approval of the training program, procedure and courseware to assure adequacy, repeatability, effectiveness and adherence to GMP and SOPs
Provide assurance that training programs are adequate, properly administered and documented for all personnel involved in GMP plant
Support the system for management and assessment of supplier, contract manufacturers or contract laboratories
Ensure that a Pest Control Program for the plant is in place and regularly monitored
Ensure that there is a system in place to review of GMP IT systems, including the system governing access authorization and the assignment of access levels for specific functions and maintaining Data Integrity
Ensure the overview of calibration and maintenance activities
Establish structured procedure to maintain housekeeping of the pant as per GMP requirement
Encourage, motivate, guide and support GMP team

?Working with one of the Large MNC Life Science company
Excel in leadership role

If interested please mail your resume on nayna.k@randstad.in.

Client Introduction
?One of the Leading MNC Lifescience Company


?Quality assurance, quality, QA, GMP, Good Manufacturing Practice, ISO, Plant Manager


?Bachelor or Master Degree in Science or Pharmacy of Engineering
Relevant experience in Quality Assurance and/or as a Plant Manager
Experience in implementing GMP/ CGMPs, ISO Standards
Well acquainted with FDCE regulations and ICH guidelines
Proficient in Advanced Computer Operations and Skills
Preferred Certified Auditor to adhere with Quality System