QA Manager

Role & responsibilities

1.QA Functional activity.

2.Maintaining and improving departmental operational performance, to meet the requirements of regulatory authorities, company Standard Operating Procedures (SOPs) and external and internal customers, with respect to quality, service, lead time and cost.

3.To face internal and external audits including Regularity audit and Acting as the main point of contact on all Quality matters, internally and externally

4.To ensure implementation of cGMP, Quality system and safety norms in plant.

5.Review and handling of change control, deviation, Incidents, customers complaints, OOS and OOT.

6.Leading customer and regulatory audits/inspections, and review regulatory and customers observation and report.

7.Ensuring that all activities are performed in accordance with GMP, company SOPs and Health and Safety policies.

8.Providing direction and guidance to the Quality team and train to subordinate for QA activities.

9.Review the Annual product Quality review and take appropriate recommended actions as identified.

10.Managing all validation activities, including validation strategy and approval of protocols and reports.

11.Release the finish product for sale.

12.Handling of returned finished products and finished products salvaging.

13.Reviewing and approving of Technical and Quality Agreements.

14.Approval of documents related to GMP, SOP, BMR, BPR , Specification, STP , SOP index and other GMP documents.

15.Implementing and assuring a Quality Risk Management system to ensure that risks are adequately controlled in accordance with current requirements.

16.To conduct the self-inspection program and review and approved of Self inspection CAPA.

17.Assuring that the supplier and subcontractor audits are performed and reported as scheduled and review of vendor document, approval of vendor and other vendor related activity.

18.To co-ordinate with other department for implementation of any new system and modification of current system.

19.Working with all members of staff to maintain and develop the positive progressive culture within company.

20.To ensure the training are perform as per schedule.

21.Review and take corrective action of day to day problem.

22.To carry out any additional responsibility given by the Senior or Director.

23.To ensure the training are perform as per schedule.

24.Master review in Pharma cloud.

25.BMR,BPR and MFR review in Pharma cloud.

26.BMR,BPR and MFR review.

27.Trend data approval activities.

28.Master serial adding in pharma cloud.

29.Cross verification of Validation master plan efficiency and compliance.

30.Out side Calibration and validation activities cross verification with Maintenance and other departments.

31.Approval of Art work, APQR and Trend data.

Preferred candidate profile

Candidates from Gujarat will be preferred.

Perks and benefits

Transportation From Gota&CTM

Bonus

PF

Paid Leaves