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: QUALITY ASSURANCE EXECUTIVE
No.of post: 2
Tasks
Responsibilities of QA Executive:
1) Evaluating current written procedures and assisting in drafting and implementing new procedures to ensure R&D activities comply with the appropriate GXP (GLP, GCP, GMP, GDP, etc.) requirements to ensure these R&D activities generate data that are accurate, and have integrity and quality. The QA executive will assist in the design, development, implementation, and maintenance of an R&D Standard Operating Procedure (SOP) system.
2) Reviewing and providing comments on R&D SOPs and study protocols for consistency with GXP and guidance requirements.
3) Advising and interacting with R&D colleagues regarding quality assurance and appropriate GXP requirements for R&D studies and activities.
4) Coordinate the harmonization and development of common written procedures for activities and processes common to all of R&D in order to facilitate the conduct of globally accepted research studies and avoid duplication of efforts.
5) Evaluating potential external research facilities, contractors, and investigators for compliance with the appropriate GXP requirements and R&D quality expectations.
6) Being responsible for the appropriate inspection and auditing of all R&D studies for compliance with applicable GXP (including Part 11) requirements. Inspection and audit findings will be reported to Study Directors/Investigators, Monitors, and Management.
7) The QA Executive will serve as the primary R&D contact for inspections of study sites by regulatory authorities and being present for these inspections as necessary. Formulating a response to inspection reports. The outcome of such inspections will be evaluated and utilized to implement process improvements in R&D.
8) Cooperation with Regulatory Affairs management and staff in developing mutually beneficial systems and procedures that will improve the overall quality of regulatory submissions and efficiency of the regulatory submission process.
9) Advising of new requirements for R&D activities. The QA Executive will participate on external and internal work groups regarding GXP and other regulatory or industry requirements for R&D. The QA will participate in national and international QA professional organizations (e.g., SQA) to keep abreast of changes and developments and to demonstrate HLL’s commitment to leadership in the research QA profession.
10) The Quality Assurance executive (R&D) reports to the Head (R&D) and supports the transfer of projects to commercial production.
Other responsibilities include:
1) Document Review & Approval such as method validations, manufacturing records, and process or analytical variances.
2) Approve and monitor corrective & preventative actions.
3) Evaluates if there is any quality impact to process/product and take appropriate action.
4) Review and approve Batch records, SOPs, Change Controls, Validation Reports and Equipment Qualification for Clinical trial materials.
5) Product Development and Technical Services Support: Transfer projects to commercial production.
6) Communicate with Contract Customers regarding quality related issues and Quality Agreements.
7) Prepare Product Development and Technical Services for PAIs (Pre-Approval Inspections) for Clinical trial manufacturing.
8) Industry Regulations: Stay informed of cGMP trends, FDA and ICH guidelines with application to product development.
9) Keep informed of product transfer and methods transfer
10) Implement Quality Improvement Projects as needed.
11) Support R&D and Product Supply and provide assistance in project / technology / method transfer to commercial QA/QC.
12) Participate in development of GMP training program, on job documentation training for R&D personnel and provide on-going GMP training to the R&D associates.
13) Prepare Quality Agreement with new 3rd party / contract labs as required by the development team.
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Requirements
Maximum Age: 40 Years as on 01/07/2015.
Consolidated Pay Scale: Rs. 25,000-40,000/- (for Deputy Manager)/ Rs. 30,000-50,000 (for Manager)
Qualification:
Essential: M.Pharm (QA/ Pharmaceutics)
Post Qualification Experience:
Essential: 1 Year for deputy Manager and 3 years for Manager. Experience in FDA regulated environment, with experience in USFDA, EU or MHRA audits
Desirable: 1) Experience in laboratory practices, release of materials and products and conducting investigation.
2) Previous GMP system management experience.
3) Strong written and verbal communication skills, specifically in technical writing communications and oral presentations.
Additional Information:
Experience: 1-3 Years
Industry Type: Pharma/Biotech/Clinical Research
Reference Code: HLL/CRD/HR/2015/QA
Salary Range (Rupee): Rs. 25,000-40,000/- (for Deputy Manager)/ Rs. 30,000-50,000 (for Manager)
Contract Type: Fixed Term Contract Basis
Department: HLL Corporate R&D centre, Akkulam
End Date: 19th August, 2015
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