Work in HLL Lifecare for the post of ASSISTANT PLANT MANAGER (QA) - (Permanent/Contract)

HLL Lifecare Limited, a Mini Ratna Central Public Sector Enterprise under the Ministry of Health & Family Welfare, Govt. of India is a global provider of high quality healthcare products & services. With state-of-the-art manufacturing facilities spanning across India, HLL is diversifying into vaccine manufacturing, lifecare services, sanitary napkins besides engaging in procurement consultancy, healthcare infrastructure development and facility management.

Post: ASSISTANT PLANT MANAGER (QA) - (Permanent/Contract)

Tasks
• To assure the quality of products of all dossiers.
• Has knowledge about all dosage forms including tablets /capsules etc & their quality specifications.
• Prepare controlled documents and distribute, retrieve, archive and destroy controlled documents. Support for dossier filing and regulatory queries and prepare new documents as per cGMP requirement, as and when required.
• Prepare employee training curriculum, annual schedules and coordinate with internal trainers and execute the training as per schedule. Maintain, check and update the training records. Assess the GMP/ On-job training evaluation questionnaires and conclusion of re-training requirements.
• Track and highlight deviations during operations to manager & maintain all documents related to deviation handling.
• Initiate the change control with necessary document support and execute the approved changes as per the action plan. Prepare the validation protocols and reports and verify documents with current equipment capability. Execute the validation/qualification processes at each stage of manufacturing.
• Prepare and update the vendor list as per the schedule and initiate the vendor evaluation documents.
• Prepare the PQR report and summarize the data collected in PQR preparation, as well as assist the manager in preparing recommendations based on PQR evaluation.
• Responsible for performing various IPQA oversights during the manufacturing operations, product simulation activities, and campaign change activities and validations.
• Preparation and review of the DQ, IQ, PQ, Risk Analysis protocols, validation documents, trend analysis reports.
• Review and closure of the CAPA activities.
• Participation in the internal audit and review of the internal audit documents. Assistance in the external audit.
• Issue, Review of Logbooks, Batch Records for all enclosures, data entries etc. and submit to Manager QA for approval. Perform pre-dispatch inspection of finished products before release.
• Preparation and review of SOP’s, STP’s, Protocols, specifications and Technical Documents and submit to Sr. Executive QA for checking & Manager QA for approval.
• Handling &Review of OOS/OOT and to participation in investigations
• To carry out routine inspection of stores, manufacturing area and QC laboratory for GMP Compliances.
• Execution support of Qualification and re-qualification and validation activity of Facility/Equipment/Utility etc. Execution support of Hold time study, Cleaning Validation Study, Process Validation.

Requirements
Maximum Age: 37 years as on 01/06/2014
Scale of Pay (For Regular Appointment): Rs. 12600 - 32500
Pay: Annual CTC 4.9 Lacks (approx.) at the minimum of the scale.
Consolidated Pay Range (For Fixed Term Contract Engagement)- Rs.20000 - 32000 per month (inclusive of all allowances & benefits)

Find More Info Go to Next Page...

Subscribe to Pharmatutor Job Alerts by Email

Qualification:
Essential: B. Pharm with experience in reputed Pharma Company.
Desirable: M. Pharm (QA or Pharmaceutics)

Post Qualification Experience:
Essential: 2 to 3 years experience for B. Pharm candidates only.
Desirable: M.Pharm candidates preferably with one year experience. B.Pharm candidates-One year experience in MNC with USFDA/ MHRA/ EU/ WHO approvals.

Additional Information:
Experience: 2-3 years
Education: B.Pharm, M.Pharm (QA or Pharmaceutics)
Reference Code: HLL/HR/052/2014
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: QA
End Date: 18^th June, 2014