Reporting to : Head Quality Position
Experience : Approximately 12 - 18 years
Qualification : M.Sc./ B.Pharm / M.Pharm
To ensure that the plant is ready for any regulatory inspection.
To train the personnel for cGMP requirements and to create a quality culture at the plant.
To review and approve validation master plan and subsequent process validation/ cleaning validation.
Shall lead the team for OOS/Deviation/Change control/document control and other quality system investigations.
Review and approval of DQ/IQ/OQ/PQ data generated for each equipment/ instrument/ utility (including DM/Purified water plant) used for the manufacturing / packing of finished drug products.
Storage, retrieval and maintenance of executed BPR I & II / approved process validation protocol and evaluation data other various technical documents / records generated as per cGMP requirements.
To review/ approve the duly filled batch manufacturing and packaging records received from production department generated as per master production records I & II and release / reject the batch for final despatch after necessary quality review.
Handling of market complaints, returned goods and product recall as per the prescribed procedures.
Co-ordinating the execution of Self inspection schedule as per cGMP requirement.
To keep self updated w.r.t. respective international /national regulations as he/she will independently handle various audits from customers and international regulatory authorities like USFDA, MHRA, TGA, ANVISA, WHO.
To ensure annual product review is completed as per the timeline and the review of control samples of finished products as per the procedure.
Team Management - Performance Goal Setting for team, Review team performance and provide feedback, coaching and counselling to ensure team effectiveness.
Proposing Process, Efficiency, Productivity, Quality and Yield improvement measures & working in close association with Production for implementing the same.
Interfaces: Internal Coordinate with other departments to achieve site and overall organisation goals Co-ordinate with all concerned departments/ units/HO for providing cost effective services and achieving excellence
Interfaces: External Customers FDA
Salary: Not Disclosed by Recruiter
Industry:Pharma / Biotech / Clinical Research
Employment Type:Permanent Job, Full Time
Desired Candidate Profile
UG:B.Pharma - Pharmacy
PG:MS/M.Sc(Science) - Chemistry, M.Pharma - Pharmacy
Unichem Laboratories Ltd
Contact Company:Unichem Laboratories Ltd