Accuprec Research Labs Pvt Ltd. is FDCA approved, OECD-GLP, NABL accredited and ISO 9001:2015 certified CRO. Head Quarter of the CRO is located at Ahmedabad and branch offices at Canada and USA. Accuprec provides all type of Pharmaceutical testing solutions to its domestic and MNC clients. Accuprec requires below mentioned staff.
Post : Manager - QA Department
Qualification & Experience : M.Sc./ M.Pharm. with Min. 10 Years of Experience
Location : Ahmedabad
Job Description
• Approval of Apex level documents like Site master file, Quality manual, Validation Master plan.
• Responsible for approval of SOPs, STPs, Calibration Planner, Preventive maintenance Schedule, Training schedule, Equipment list, SOP index, Analyst qualification, Executed calibrations and Validation Master Plan.
• Responsible to approve Quality Agreements.
• Responsible to approve Job responsibilities of each employee at ARL, organogram/functions of all departments.
• Responsible to approve lay outs and drawings.
• Responsible to approve TNID, training attendance sheet, training intimation sheet, utility list.
• Responsible to approve induction Programme of each employee.
• Responsible to approve certification each employee after completion of training.
• Responsible to check technical feasibility of contracted consultant.
• Responsible to approve Breakdown memo of instrument/equipment.
• Responsible to approve BMR/BPR and MFR.
• Handling of sub-contracting procedure.
• Responsible to approve internal audit planner.
• To conduct Management Review Meeting in coordination with all departments HOD.
• Participate in investigation and impact assessment of OOS, Deviation, Lab Incident, Incident, Change Control and Market Compliant.
• Responsible to follow the Good Document Practices.
• Responsible to Execute Internal Audit as auditor and Auditee.
• To handle the different regulatory and client inspections for premises with respect to compliance and to fulfill the query (if any) by preparation/review/approval of relevant documents and necessary effective systems/procedure.
• Responsible for approval of regulatory as well as external client audit compliance report.
• Responsible for vendor qualification.
• Responsible to impart schedule as well as conceptual training as per the planner or any need base training.
• Responsible to review application documentation pertaining to FDCA, ISO, GLP, CPCSEA, NABL, AYUSH, DSIR, CDSCO, DUNS and USFDA etc. and compliance thereof.
• Responsible for the approval and rejection of QMS documents like change control form, deviation, CAPA, incidents, market complaints, OOS, OOC.
Mention your ON HAND SALARY, EXPECTED CTC and NOTICE PERIOD.
Interested Candidate can Send CV on career@accuprec.in
Last Date : 25th June, 2023
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