HLL Lifecare Limited QA & QC Deputy Manager – Applications Invited
HLL Lifecare Limited (HLL) is a Govt. of India Healthcare products manufacturing and
services Company based in Thiruvananthapuram, Kerala, India under the Union Ministry of
Health and Family Welfare, HLL is a global leader in the area of contraceptives, hospital
products and healthcare services. With 7 manufacturing units, 5 subsidiary companies and
having a presence in more than 100 countries, HLL is positioned as a total healthcare solution provider catering to the well-being of society at large.
Job Title: DEPUTY MANAGER (QA/QC and PRODUCT CERTIFICATION) (on
REGULAR BASIS)
Department: HLL- AKKULAM FACTORY
Maximum Age: 45 Years as on 01/12/2021
Scale of Pay (For Regular Appointment): 16400 – 40500/-
Annual CTC: – Rs.8.3 lakhs (approx.) at the minimum of the scale.
Qualification
Essential: M.Pharm
Desirable: PhD
Post Qualification Experience
Essential: Minimum Five years relevant experience in Quality Assurance of sterile
medical devices
No. of Position: 01
Posting Location: Trivandrum
Contract Type: Regular
Overall Job Summary :
The Deputy Manager (QA/QC and Product Certification) shall monitor and coordinate the QA & QC activities for Sterile Medical Device manufacturing, meeting the regulatory
requirements both Domestic and international as applicable Prepare and review
Duties and Responsibilities
1. QA/ QC activities during the commercial production of the Sterile Medical Devices
2. Preparation of Quality Manual, technical files, Clinical Evaluation records, Product
dossier, Site master file, Validation documents, and Stability records in line with the
national &international regulations.
3. Analytical method validation as per the current regulatory requirements.
4. Coordination and performing the Customer Feedback collection, customer complaint
redressel, post Market clinical follow up, Clinical Investigation, Clinical Evaluation and
Risk Management.
5. Qualification of Lab & Production Equipments
6. Preparation, review, evaluation, and approval of change control procedures, CAPA,
deviations/ investigations, OOS/OOT investigations, and in processes QA reports.
7. Coordinating with both internal and external interested parties
8. Coordinating with Regulatory affairs Department for manufacturing License and
associated product approvals
9. Supervising and training the Quality operators for GMP, GLP, and Documentation
practices
10. Coordinating with Microbiology lab analysis and sterility testing
11. Coordinate with cross functions for audit schedule, Audit findings and corrective
actions, and preparation of audit compliance report.
Skills & Competency required for the job
1. Good knowledge of production and quality concepts extending to Sterile Medical
Device production and testing.
2. Awareness in international legislations, guidelines and regulatory requirements
pertaining to Sterile medical device manufacturing and testing.
3. Expertise in handling regulatory requirements and performing stability studies inline
to regulatory requirements (i.e. MDR, ICH, and UNFPA).
4. Competent in review and documentation of analytical Method validation as per the
current ICH and regulatory guidelines
5. In-depth understanding on GMP,GLP and Good Documentation Practices
6. Competent in preparation of Quality Manual, technical file, clinical Evaluation
records, Product dossier, Site master file, Validation documents and Stability records
in line with the national & international regulations.
7. Competent in handling regulatory & customer audits and auditing knowledge as per
ISO/GMP/IMDR/EUMDR/WHO and other required quality standards.
8. Good knowledge in Microbiological analysis/ sterility testing
9. Exposure to ISO 17025, ISO 9001, ISO 13485, IMDR, EUMDR, WHO and associated product standards/ regulatory requirements.
10. Updated knowledge of latest QA/QC techniques and data interpretation.
How To Apply:
candidates are advised to send the necessary documents to [email protected] on or before 05.01.2022. Essential documents to be forwarded are:
1. Duly filled Application Form (Photo must be affixed)
2. Educational Qualifications (10th/ 12th/ Graduation/ PG (as per the advertisement)/
Other Additional Qualifications)
3. Post Qualification relevant Experience (As per the advertisement). Without necessary
documents like Experience Letter/ relieving Letter/ joining documents, the experience
required will not be counted. No further communication will be sent to the candidates
in this regard. Candidates are advised to attach all relevant experience-related
documents carefully.
4. Updated CV with Mobile Number and email address
5. Community Certificate (for SC/ST/ OBC)or Disability Certificate (for PH)
6. Latest Payslip
7. Aadhar card
Please mention the subject as “Application for DEPUTY MANAGER (QA/QC and
PRODUCT CERTIFICATION) position”
Incomplete applications will be rejected and no further communication will be shared in this
regard. The detailed Job description is given below for reference.
Editors Note: HLL Lifecare Limited QA Subscribe to Rasayanika for the latest chemistry and Pharma job openings, follow us on Facebook and Telegram and subscribe to our youtube channel for the latest updates on chemistry and Pharma jobs and much more.
