Responsible for implementing and maintaining the effectiveness of the quality systems.
Provide support to the site during Regional internal audits and action plan preparation.
Responsible for implementing and maintaining the activities of the QA Internal audits at site.
Responsible for the handling the site change control activities on SolTRAQs.
Provide support to QA/QC staff and all Departmental SOPs Coordinators for revision / new SOPs against the requirement of Abbott divisional and corporate policies, cGMP, ISO, WHO, Drugs Act, 1976 and Class A, for good Quality Systems.
To evaluate need of training upon revision or introduction of a new system / procedure and arrange / coordinate with the help of expertise available for QA SOPs / Procedures.
Principal Duties:
To make sure that activity related area does not result in: a. Delay or non-availability of product b. Delay in introduction of new products c. Delay in implementation of CIP. d. Failure of the team. e. Compromise on quality GMP and GLP.
To review, comment, and finalize with Compliance and Quality System Manager, all new and revised Abbott divisional and corporate policies and ensure implementation of practices, in the form of SOPs and ensure compliance of SOPs QA-015-01 and QA-111-01
To provide help to QA staff, in preparation of action plan for QA Internal audit as well as Regional Internal audits.
Review Action plans of QA internal audits and Regional internal audits and follow up for the closure of approved action plan for QA Internal audits as well as Regional internal audits.
For effective control of activities in QA Section, perform implementation audits, remove deficiencies with the help of concerned group leader or where needed with the help of Manager Compliance and Quality System.
Responsible to support all ISOtrain users for the compliance of training as per their timelines.
Responsible to manage all DARIUS system activities for the Document Management and provide support to all DARIUS users at site.
Management of modules, user access roles and courses in ISOtrain of all employees.
To coordinate / monitor compliance of SOPs review system within Site as per SOP QA-015-01.
To Plan / organize and control activities in the area and to discuss action taken in case of anticipated crossing of lead times (as defined in current year's Goals so as to bring it within the agreed upon lead time). If any problem in attaining workload, should discuss with Compliance and Quality System Manager.
Involvement in compliance issue along with Compliance and Quality System Manager as and when required.
Any other job assigned by Compliance and Quality System Manager.
Knowledge & Experience:
Knowledge of QA Internal Audits, Change Control activities and other compliance activities taking place in Quality Department.
06-08 years of experience in relevant filed.
Minimum Qualifications:
Pharm-D / M.Sc. Chemistry
The base pay for this position is
N/A
In specific locations, the pay range may vary from the range posted.
JOB FAMILY:Operations QualityDIVISION:EPD Established PharmaLOCATION:Pakistan > Karachi : Opp: Radio Pakistan Transmission, Hyderabad Road, LandhiADDITIONAL LOCATIONS:WORK SHIFT:StandardTRAVEL:NoMEDICAL SURVEILLANCE:Not ApplicableSIGNIFICANT WORK ACTIVITIES:Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous walking for prolonged periods (more than 2 hours at a time in an 8 hour day)
