Roles and Responsibilities
-To co-ordinate with shop floor QA team to ensure that GMP requirement is being followed at various stages of production and packing activities.
-To review major GMP observation and corrective actions taken in co-ordinate with shop floor QA team.
-To review corrective action taken for critical GMP observation and plan for preventive action in co-ordinate with concerned department.
-To organize for preparation, modification & review SOPs for critical activity and to ensure that activity is done as per schedule.
-To monitor the follow-up & implementation of SOPs.
-To identify the training requirement and to organize for training of sub-ordinates and maintain records of same.
-To provide training to Shop floor staff for implementation of SOPs & GMP compliance.
-To review E-BMR & E-BPR for its completeness and correctness.
-To implement validation master plan by planning the activity accordingly.
-To organize for calibration of instrument identified within specified calibration period.
-To organize for validation of manufacturing process identified for validation as per requirement.
-To review deviation appropriately and ensure that action plan is implemented suitably once it is approved.
-To ensure that change after appropriate approval is implemented as per plan suggested.
-To investigate market complaint & prepare investigation report.
-To investigate failure, non-compliance, and critical cGMP failure and GLP failure & necessary corrective action is planed and implemented.
-Handling of Risk assessment related to product, process, equipment and wherever applicable.
-To Prepare APQR and review APQR for its completeness and correctness.
-To ensure that adequate housekeeping is done.
-To coordinator site regulatory to HO regulatory. To review of new registration data or re-registration data as per country requirement.
-To issue and retrieve the registration data or re-registration data to production, Quality Control or Quality Assurance department. To provide the document as per requirement of HO Regulatory Department.
-SAP related activity and any other work assign by supervisor.
-To execute qualification/requalification activity of equipment/system, temperature mapping activity of the area.
-To ensures the batches are released or rejected after adequate verification of related documents for domestic and export product.
-Handling of computer system validation and its implementation.
Desired Candidate Profile
B.Pharm / M.Pharm completed, Should have Experience in pharma formulation i.e. Tablet Mfg. Plant.
Role:Quality Assurance/Quality Control Executive
Salary: 2,75,000 - 7,00,000 P.A.
Employment Type:Full Time, Permanent
UG:B.Pharma in Pharmacy
PG:M.Pharma in Pharmacy
J B Chemicals and Pharmaceuticals Ltd.
JBCPL is widely committed to manufacturing a range of innovative specialty products that include various pharmaceutical dosage forms like tablets, injectable (vials, ampoules, form fill seal), creams &amp;amp; ointments, lozenges, herbal liquids and capsules.
JBCPL has its headquarters in India&amp;rsquo;s financial capital, Mumbai. With a domestic sales force of 1,000 people, 17 internationally approved state of the art manufacturing units, a Research and Development Centre, and subsidiaries abroad, the organisation is continually enhancing value for its shareholders.
In India and International markets, JBCPL is also known as Unique Pharmaceutical Laboratories and is a division of JBCPL.
Contact Company:J B Chemicals and Pharmaceuticals Ltd.
Address:UNIT A2,8th FLOOR,CNERGY IT PARK,APPA SAHEB MARATH, E MARG,WORLI PRABHADEVI, , MUMBAI, Maharashtra, India